Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading,
diversified specialty pharmaceutical company committed to improving
the lives of people living with serious medical conditions, today
announced that 10 poster presentations highlighting data regarding
its diversified pain portfolio will be presented at PAINWeek
Conference 2023, being held in Las Vegas, NV from September 5–8,
2023.
“Collegium is dedicated to responsible pain management and
leading with science. We are pleased to present 10 posters with new
real-world data at PAINWeek 2023 that underscore the clinical and
population health impact of our portfolio and provide significant
insights for healthcare decision makers who treat people
experiencing pain,” said Thomas Smith, M.D., Chief Medical Officer
of Collegium. “We welcome opportunities to share clinical and
real-world data with the medical community as part of our
commitment to improving the lives of people living with serious
medical conditions.”
The following poster presentations will also be available on the
PAINWeek Conference 2023 website on Wednesday, September 6, 2023,
from 3:30 – 4:30 p.m. PT and on Thursday, September 7, 2023, from
3:30 – 5:30 p.m. PT.
Poster Presentations:
Poster Title: |
Healthcare Cost and Resource Use in Chronic Low Back Pain Patients
Treated with Belbuca® and Buprenorphine Transdermal
Patches: A Retrospective US Commercial Claims Analysis |
Authors: |
Vladimir Zah, Filip Stanicic, Todd Kunkel, Djurdja Vukicevic,
Dimitrije Grbic |
|
|
Poster Title: |
Treatment Characteristics of Chronic Low Back Pain Patients Treated
with Belbuca® and Buprenorphine Transdermal
Patches: A Retrospective US Commercial Claims Analysis |
Authors: |
Vladimir Zah, Filip Stanicic,
Todd Kunkel, Djurdja Vukicevic, Dimitrije Grbic |
|
|
Poster Title: |
Safety and Tolerability of Buprenorphine and Oral Schedule II
Opioid Treatment in Chronic Low Back Pain Patients: A
Retrospective US Commercial Claims Analysis |
Authors: |
Vladimir Zah, Filip Stanicic,
Todd Kunkel, Djurdja Vukicevic, Dimitrije Grbic |
|
|
Poster Title: |
Healthcare Costs Associated with Rates of Prescription Opioid
Misuse/Abuse |
Authors: |
Jody L. Green, Taryn Dailey-Govoni, Suzanne K. Vosburg |
|
|
Poster Title: |
Sustained Risk Reduction of Severe Clinical Outcomes Following
Misuse/Abuse of XTAMPZA® ER as Compared to Other
Prescription Opioids |
Authors: |
Jody L. Green, Taryn Dailey-Govoni, Suzanne K. Vosburg |
|
|
Poster Title: |
Differences in the Severity of Medical Outcomes of Exposures
Reported to Poison Centers Involving XTAMPZA® ER and
Other Opioid Analgesics |
Authors: |
Brooke Kritikos, Stevan Severtson, Joshua C. Black, Heather Olsen,
Janetta Iwanicki, Richard C. Dart |
|
|
Poster Title: |
Real-world Impact of Abuse-Deterrent Formulation of
XTAMPZA® ER in the Context of Behaviors Around Tampering
with XTAMPZA® ER and Other Opioid Products |
Authors: |
Evelyn Fox, Jennifer S. Jewell, Joshua C. Black, Matthew S. Ellis,
Heather Olsen, Hannah L. Burkett, Janetta Iwanicki, Richard C.
Dart |
|
|
Poster Title: |
Use of Causal Framework to Evaluate Effect of Abuse Deterrent
Properties of XTAMPZA® ER on Opioid Tampering in a
Post-Market Setting |
Authors: |
Karilynn M. Rockhill, Hannah L. Burkett, Richard C. Dart, Joshua C.
Black |
|
|
Poster Title: |
Changes in Oxycodone Misuse and Abuse Trends Across COVID-19: A
Look Back |
Authors: |
Jennifer S. Jewell, Karilynn M. Rockhill, Joshua C.
Black, Hannah L. Burkett, Matthew S. Ellis, Sabrina
Kaplan, Richard C. Dart |
|
|
Poster Title: |
Association Between Per Capita Prescribing and Abuse
of Tapentadol and Other Opioids Among Individuals
Entering Treatment For Opioid Use Disorders |
Authors: |
Megan Healy, Stevan Severtson, Annika Czizik, Matthew S. Ellis,
Joshua C. Black, Heather Olsen, Janetta Iwanicki, Richard C.
Dart |
For more information on PAINWeek Conference 2023, visit:
https://www.painweek.org/.
Xtampza® ER (oxycodone) extended-release capsules, CII,
Nucynta® ER (tapentadol) extended-release tablets, CII,
and Nucynta® (tapentadol) tablets, CII, can be abused or
misused, and carry a risk of addiction. These products are intended
for use only in appropriate pain patients and only when other
treatment alternatives are inadequate. Use of Xtampza® ER,
Nucynta® ER and Nucynta® can result in serious,
life-threatening or fatal respiratory depression, even when used
exactly as prescribed. See Important Safety
Information, including Boxed Warning on addiction, abuse, and
misuse and other serious risks regarding each of these three
products at the end of this press release.
About Collegium Pharmaceutical, Inc.
Collegium is a diversified, specialty pharmaceutical company
committed to improving the lives of people living with serious
medical conditions. Collegium’s headquarters are located in
Stoughton, Massachusetts. For more information, please visit the
Company’s website at www.collegiumpharma.com.
INDICATIONS AND USAGE
Xtampza® ER
(oxycodone) is:
- A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage pain severe enough to require
daily, around-the-clock, long-term treatment with an opioid when
other pain treatments, such as non-opioid pain medicines or
immediate-release opioid medicines, do not treat your pain well
enough or you cannot tolerate them.
- A long-acting (extended-release) opioid pain medicine that can
put you at risk for overdose and death. Even if you take your dose
correctly as prescribed by your healthcare provider, you are at
risk for opioid addiction, abuse, and misuse that can lead to
death.
- Not for use to treat pain that is not around-the-clock.
IMPORTANT SAFETY INFORMATION ABOUT XTAMPZA
ER
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS |
Addiction, Abuse, and MisuseXtampza ER
exposes patients and other users to the risks of opioid addiction,
abuse, and misuse, which can lead to overdose and death. Assess
each patient’s risk prior to prescribing Xtampza ER and monitor all
patients regularly for the development of these behaviors or
conditions.Opioid Analgesic Risk Evaluation and
Mitigation Strategy (REMS)To ensure that the
benefits of opioid analgesics outweigh the risks of addiction,
abuse, and misuse, the Food and Drug Administration (FDA) has
required a REMS for these products. Under the requirements of the
REMS, drug companies with approved opioid analgesic products must
make REMS-compliant education programs available to healthcare
providers. Healthcare providers are strongly encouraged to
- complete a REMS-compliant education
program,
- counsel patients and/or their caregivers, with every
prescription, on safe use, serious risks, storage, and disposal of
these products,
- emphasize to patients and their caregivers the
importance of reading the Medication Guide every time it is
provided by their pharmacist, and
- consider other tools to improve patient, household, and
community safety.
Life-Threatening Respiratory
DepressionSerious, life-threatening, or fatal
respiratory depression may occur with use of Xtampza ER. Monitor
for respiratory depression, especially during initiation of Xtampza
ER or following a dose increase.Accidental
IngestionAccidental ingestion of even one dose of
Xtampza ER, especially by children, can result in a fatal overdose
of oxycodone.Neonatal Opioid Withdrawal
SyndromeProlonged use of Xtampza ER during
pregnancy can result in neonatal opioid withdrawal syndrome, which
may be life-threatening if not recognized and treated, and requires
management according to protocols developed by neonatology experts.
If opioid use is required for a prolonged period in a pregnant
woman, advise the patient of the risk of neonatal opioid withdrawal
syndrome and ensure that appropriate treatment will be
available.Cytochrome P450 3A4
InteractionThe concomitant use of Xtampza ER with
all cytochrome P450 3A4 inhibitors may result in an increase in
oxycodone plasma concentrations, which could increase or prolong
adverse drug effects and may cause potentially fatal respiratory
depression. In addition, discontinuation of a concomitantly used
cytochrome P450 3A4 inducer may result in an increase in oxycodone
plasma concentration. Monitor patients receiving Xtampza ER and any
CYP3A4 inhibitor or inducer.Risks From Concomitant
Use With Benzodiazepines or Other CNS
DepressantsConcomitant use of opioids with
benzodiazepines or other central nervous system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death.
- Reserve concomitant
prescribing of Xtampza ER and benzodiazepines or other CNS
depressants for use in patients for whom alternative treatment
options are inadequate.
- Limit dosages and durations to
the minimum required.
- Follow patients for signs and
symptoms of respiratory depression and sedation.
|
Important information about Xtampza
ER:
- Get emergency help or call 911 right away if you take
too much Xtampza ER (overdose). When you first start
taking Xtampza ER, when your dose is changed, or if you take too
much (overdose), serious life-threatening breathing problems that
can lead to death may occur. Talk to your healthcare provider about
naloxone, a medicine for the emergency treatment of an
overdose.
- Taking Xtampza ER with other opioid medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including
street drugs) can cause severe drowsiness, decreased awareness,
breathing problems, coma, and death.
- Never give anyone else your Xtampza ER. They could die from
taking it. Selling or giving away Xtampza ER is against the
law.
- Store Xtampza ER securely, out of sight and reach of children,
and in a location not accessible by others, including visitors to
the home.
Do not take Xtampza ER if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage, or have narrowing of the stomach or
intestines.
Before taking Xtampza ER, tell your healthcare provider
if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction,
opioid overdose, or mental health problems
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant.
Prolonged use of Xtampza ER during pregnancy can cause withdrawal
symptoms in your newborn baby that could be life-threatening if not
recognized and treated.
- breastfeeding. Not recommended during
treatment with Xtampza ER. It may harm your baby.
- living in a household where there are small children or someone
who has abused street or prescription drugs.
- taking prescription or over-the counter medicines, vitamins, or
herbal supplements. Taking Xtampza ER with certain other medicines
can cause serious side effects that could lead to death.
When taking Xtampza ER:
- Do not change your dose. Take Xtampza ER exactly as prescribed
by your healthcare provider. Use the lowest dose possible for the
shortest time needed.
- Take your prescribed dose every 12 hours, at the same time
every day. Do not take more than your prescribed dose. If you miss
a dose, take your next dose at your usual time.
- If you cannot swallow Xtampza ER capsules, see the detailed
Instructions for Use in the Medication Guide.
- Always take Xtampza ER capsules with approximately the same
amount of food to ensure enough medicine is absorbed.
- Swallow Xtampza ER whole. Do not snort, or inject Xtampza ER
because this may cause you to overdose and die.
- The contents of the Xtampza ER capsules may be sprinkled on
soft food, sprinkled into a cup and then put directly into the
mouth, or given through a nasogastric or gastrostomy tube.
- Call your healthcare provider if the dose you are
taking does not control your pain.
- Do not stop taking Xtampza ER without talking to your
healthcare provider.
- Dispose of expired, unwanted or unused Xtampza ER by promptly
flushing down the toilet, if a drug take-back option is not readily
available. Visit www.fda.gov/drugdisposal for additional
information on disposal of unused medicines.
While taking Xtampza ER, DO NOT:
- Drive or operate heavy machinery, until you know how Xtampza ER
affects you. Xtampza ER can make you sleepy, dizzy, or
light-headed.
- Drink alcohol or use prescription or over-the-counter medicines
that contain alcohol. Using products containing alcohol during
treatment with Xtampza ER may cause you to overdose and die.
The possible side effects of Xtampza ER
are:
- constipation, nausea, sleepiness, vomiting, tiredness,
headache, dizziness, and abdominal pain. Call your healthcare
provider if you have any of these symptoms and they are
severe.
Get emergency medical help or call 911 right away if you
have:
- trouble breathing, shortness of breath, fast heartbeat, chest
pain, swelling of your face, tongue, or throat, extreme drowsiness,
light-headedness when changing positions, feeling faint, agitation,
high body temperature, trouble walking, stiff muscles, or mental
changes such as confusion.
These are not all the possible side effects of Xtampza ER. Call
your doctor for medical advice about side effects. You may report
side effects to the FDA at 1-800-FDA-1088. For more
information, go to dailymed.nlm.nih.gov.
See full Prescribing Information, including Boxed
Warning on Addiction, Abuse and Misuse and other serious risks, and
the Medication Guide accompanying this piece or at
XtampzaER.com/PI. Speak to your healthcare provider if you have
questions about Xtampza ER.
APPROVED USE
BELBUCA®
(buprenorphine buccal
film) CIII
is:
- A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage pain severe enough to require
daily, around-the-clock, long-term treatment with an opioid, when
other pain treatments such as non-opioid pain medicines or
immediate-release opioid medicines do not treat your pain well
enough or you cannot tolerate them.
- A long-acting opioid pain medicine that can put you at risk for
overdose and death. Even if you take your dose correctly as
prescribed, you are at risk for opioid addiction, abuse, and misuse
that can lead to death.
- Not for use to treat pain that is not around-the-clock.
IMPORTANT SAFETY
INFORMATION about
BELBUCA®
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL
SYNDROME; and RISKS
FROM CONCOMITANT
USE WITH BENZODIAZEPINES
AND OTHER CNS DEPRESSANTS |
Addiction, Abuse, and
MisuseBELBUCA exposes
patients and
other users to
the risks of
opioid addiction, abuse, and misuse, which
can lead to overdose and death. Assess each patient’s
risk prior to
prescribing BELBUCA,
and monitor
regularly for these
behaviors and conditions.Risk Evaluation and
Mitigation Strategy (REMS)To
ensure that the
benefits of
opioid analgesics
outweigh the
risks of addiction,
abuse, and misuse,
the FDA has
required a REMS
for these
products. Under the
requirements of the REMS, drug companies with approved opioid
analgesic products must make REMS-compliant education programs
available to healthcare providers. Healthcare providers are
strongly encouraged to
- complete a
REMS-compliant education
program,
- counsel patients
and/or their
caregivers, with
every prescription,
on safe use, serious risks, storage, and
disposal of these products,
- emphasize to
patients and
their caregivers
the importance
of reading the Medication
Guide every time it is provided by their pharmacist,
and
- consider other
tools to improve
patient, household,
and community
safety.
Life-Threatening Respiratory
DepressionSerious,
life-threatening, or
fatal respiratory
depression may
occur with use
of BELBUCA. Monitor for respiratory depression, especially
during initiation of BELBUCA or following a dose increase. Misuse
or abuse of BELBUCA by chewing, swallowing, snorting, or injecting
buprenorphine extracted from the buccal
film will result
in the
uncontrolled delivery
of buprenorphine
and poses a significant risk of overdose
and death.Accidental
ExposureAccidental
exposure to even
one dose of
BELBUCA, especially
in children, can result
in a fatal overdose of buprenorphine.Neonatal
Opioid Withdrawal SyndromeProlonged use
of BELBUCA during pregnancy
can result in neonatal
opioid withdrawal syndrome, which may be life-threatening if not
recognized and treated. If
prolonged opioid
use is required
in a pregnant
woman, advise the patient
of the risk of neonatal opioid withdrawal syndrome and ensure that
appropriate treatment will be available.Risks from
Concomitant Use with Benzodiazepines Or Other CNS
DepressantsConcomitant use of opioids with
benzodiazepines or other central nervous system
(CNS) depressants,
including alcohol,
may result in
profound sedation, respiratory depression,
coma, and death. Reserve concomitant prescribing for use in
patients for whom alternative treatment options are inadequate;
limit dosages and durations to the minimum required; and follow
patients for signs and symptoms of respiratory depression and
sedation. |
Important
information about
BELBUCA:
- Get emergency help or call 911 right away if you take
too much BELBUCA (overdose). When you first start taking
BELBUCA, when your dose is changed, or if you take too much
(overdose), serious or life-threatening breathing problems that can
lead to death may occur. Talk to your healthcare provider about
naloxone, a medicine for the emergency treatment of an opioid
overdose.
- Taking BELBUCA with other opioid medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including
street drugs) can cause severe drowsiness, decreased awareness,
breathing problems, coma, and death.
- Never give anyone else your BELBUCA. They could die from taking
it. Selling or giving away BELBUCA is against the law.
- Store BELBUCA securely, out of sight and reach of children, and
in a location not accessible by others, including visitors to the
home.
Do not use
BELBUCA if you
have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or
intestines.
Before taking
BELBUCA, tell
your healthcare
provider if you
have a history
of:
- head injury, seizures
- heart rhythm problems (long QT syndrome)
- liver, kidney, thyroid problems
- tooth problems, including a history of cavities
- pancreas or gallbladder problems
- problems urinating
- abuse of street or prescription drugs, alcohol addiction,
opioid overdose, or mental health problems
Tell your
healthcare provider
if you are:
- pregnant or planning to
become pregnant. Prolonged use of BELBUCA during pregnancy
can cause withdrawal symptoms in your newborn baby that could be
life-threatening if not recognized and treated.
- breastfeeding. Not recommended during
treatment with BELBUCA. It may harm your baby.
- Living in a household where there are small children or someone
who has abused street or prescription drugs.
- taking prescription or over-the-counter medicines, vitamins, or
herbal supplements. Taking BELBUCA with certain other medicines can
cause serious side effects and could lead to death.
When taking
BELBUCA:
- Do not change your dose. Apply BELBUCA exactly as prescribed by
your healthcare provider. Use the lowest effective dose possible
for the shortest time needed.
- See the detailed Instructions for Use for information about how
to apply BELBUCA.
- Do not apply BELBUCA if the package seal is broken or the film
is cut, damaged, or changed in any way.
- After the film has adhered to your cheek, avoid eating or
drinking until the film has completely dissolved, usually within 30
minutes.
- After BELBUCA is completely dissolved, rinse your mouth with
water and swallow. Wait for at least one hour before brushing
teeth.
- Report any problems with your teeth immediately to your
healthcare provider and schedule an appointment with a dentist.
Tell your dentist that you have started taking BELBUCA.
- Avoid touching or moving the buccal film with your tongue or
fingers.
- Do not chew, swallow, snort or inject BELBUCA. This
will result in uncontrolled delivery
of buprenorphine
and may cause
you to overdose
and die.
- Call your
healthcare provider
if the dose
you are using
does not control
your pain.
- Do not stop
using BELBUCA
without talking
to your
healthcare provider.
- Dispose of expired, unwanted, or unused BELBUCA by removing the
BELBUCA film from the foil packaging, and promptly flushing down
the toilet (if a drug takeback option is not readily available).
Visit www.fda.gov/drugdisposal for additional information on
disposal of unused medicines.
While using
BELBUCA DO
NOT:
- Drive or operate heavy machinery,
until you know how BELBUCA affects you. BELBUCA can make you
sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or
over-the-counter medicines containing alcohol. Using products
containing alcohol during treatment with BELBUCA may cause you to
overdose and die.
The possible
side effects of
BELBUCA are:
- nausea, constipation, headache,
vomiting, dizziness, and sleepiness. Call your healthcare provider
if you have any of these symptoms and they are severe.
Get emergency
medical help or
call 911 right
away if you
have:
- trouble breathing, shortness of
breath, fast heartbeat, chest pain, swelling of your face, tongue
or throat, extreme drowsiness, light-headedness when changing
positions, feeling faint, agitation, high body temperature, trouble
walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of
BELBUCA. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. For
more information, go to
dailymed.nlm.nih.gov.
Please see full
Prescribing Information, including Boxed
Warning on Addiction,
Abuse, and Misuse, and other serious risks, and
Medication Guide or speak to your
healthcare provider if you have questions about
BELBUCA.
INDICATIONS AND USAGE
NUCYNTA® (tapentadol) tablets are:
- A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage short term (acute) pain in adults
and children 6 years of age and older who weigh at least 88 pounds
(40 kg), when other pain treatments such as non-opioid pain
medicines do not treat your pain well enough or you cannot tolerate
them.
- An opioid pain medicine that can put you at risk for overdose
and death. Even if you take your dose correctly as prescribed, you
are at risk for opioid addiction, abuse, and misuse that can lead
to death.
IMPORTANT SAFETY INFORMATION ABOUT NUCYNTA
TABLETS
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
NUCYNTA TABLETSAddiction, Abuse, and
MisuseBecause the use of NUCYNTA tablets exposes
patients and other users to the risks of opioid addiction, abuse,
and misuse, which can lead to overdose and death, assess each
patient’s risk prior to prescribing and reassess regularly for the
development of these behaviors and
conditions.Life-Threatening Respiratory
DepressionSerious, life-threatening, or fatal
respiratory depression may occur with use of NUCYNTA tablets,
especially during initiation of NUCYNTA tablets or following a dose
increase. To reduce the risk of respiratory depression, proper
dosing and titration of NUCYNTA tablets are
essential.Accidental
IngestionAccidental ingestion of even one dose of
NUCYNTA tablets, especially by children, can result in a fatal
overdose of tapentadol.Risks From Concomitant Use
With Benzodiazepines or Other CNS
DepressantsConcomitant use of opioids with
benzodiazepines or other central nervous system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death. Reserve concomitant prescribing of
NUCYNTA tablets and benzodiazepines or other CNS depressants for
use in patients for whom alternative treatment options are
inadequate.Neonatal Opioid Withdrawal
SyndromeIf opioid use is required for an extended
period of time in a pregnant woman, advise the patient of the risk
of Neonatal Opioid Withdrawal Syndrome which may be life
threatening if not recognized and treated. Ensure that management
by neonatology experts will be available at
delivery.Opioid Analgesic Risk Evaluation and
Mitigation Strategy (REMS)Healthcare providers are
strongly encouraged to complete a REMS-compliant education program
and to counsel patients and caregivers on serious risks, safe use,
and the importance of reading the Medication Guide with each
prescription. |
Important information about NUCYNTA
tablets:
- Get emergency help or call 911 right away if you take
too much NUCYNTA (overdose) tablets. When you first start
taking NUCYNTA tablets, when your dose is changed, or if you take
too much (overdose), serious or life-threatening breathing problems
that can lead to death may occur. Talk to your healthcare provider
about naloxone, a medicine for the emergency treatment of an opioid
overdose.
- Taking NUCYNTA tablets with other opioid medicines,
benzodiazepines, alcohol, or other central nervous system
depressants (including street drugs) can cause severe drowsiness,
decreased awareness, breathing problems, coma, and death.
- Never give anyone else your NUCYNTA tablets. They could die
from taking it. Selling or giving away NUCYNTA tablets is against
the law.
- Store NUCYNTA tablets securely, out of sight and reach of
children, and in a location not accessible by others, including
visitors to the home.
Do not take NUCYNTA tablets if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or
intestines.
Before taking NUCYNTA tablets, tell your healthcare
provider if you have a history of:
- head injury, seizures
- problems urinating
- abuse of street or prescription drugs, alcohol addiction,
opioid overdose or mental health problems
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
Tell your healthcare provider if you:
- notice your pain getting worse. If your pain
gets worse after you take NUCYNTA tablets, do not take more NUCYNTA
tablets without first talking to your healthcare provider. Tell
your healthcare provider if the pain that you have increases, if
you feel more sensitive to pain, or if you have new pain after
taking NUCYNTA tablets.
- are pregnant or planning to become pregnant.
Use of NUCYNTA tablets for an extended period of time during
pregnancy can cause withdrawal symptoms in your newborn baby that
could be life-threatening if not recognized and treated.
- are breastfeeding. NUCYNTA tablets pass into
breast milk and may harm your baby.
- are living in a household where there are small children or
someone who has abused street or prescription drugs.
- are taking prescription or over-the-counter medicines,
vitamins, or herbal supplements. Taking NUCYNTA tablets with
certain other medicines can cause serious side effects that could
lead to death.
When taking NUCYNTA tablets:
- Do not change your dose. Take NUCYNTA tablets exactly as
prescribed by your healthcare provider.Use the lowest dose possible
for the shortest time needed.
- For acute (short-term) pain, you may only need to take NUCYNTA
tablets for a few days. You may have some NUCYNTA tablets left over
that you did not use. See disposal information at the bottom of
this section for directions on how to safely throw away (dispose
of) your unused NUCYNTA tablets.
- Take your prescribed dose every 4-6 hours, at the same time
every day. Do not take more than your prescribed dose. If you miss
a dose, take your next dose at your usual time.
- Call your healthcare provider if the dose you are taking does
not control your pain.
- If you have been taking NUCYNTA tablets regularly, do not stop
taking NUCYNTA tablets without talking to your healthcare
provider.
- Dispose of expired, unwanted, or unused NUCYNTA Tablets by
promptly flushing down the toilet, if a drug take-back option is
not readily available. Visit www.fda.gov/drugdisposal for
additional information on disposal of unused medicines.
While taking NUCYNTA tablets, DO NOT:
- Drive or operate heavy machinery, until you know how NUCYNTA
tablets affect you. NUCYNTA tablets can make you sleepy, dizzy, or
lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines
that contain alcohol. Using products containing alcohol during
treatment with NUCYNTA tablets may cause you to overdose and
die.
The possible side effects of NUCYNTA
tablets:
- constipation, nausea, sleepiness, vomiting, tiredness,
headache, dizziness, abdominal pain. Call your healthcare provider
if you have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you
have:
- trouble breathing, shortness of breath, fast heartbeat, chest
pain, swelling of your face, tongue, or throat, extreme drowsiness,
light-headedness when changing positions, feeling faint, agitation,
high body temperature, trouble walking, stiff muscles, or mental
changes such as confusion.
These are not all of the possible side effects of NUCYNTA
tablets. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. For
more information, go to
dailymed.nlm.nih.gov.
See full Prescribing Information, including Boxed
Warning on Addiction, Abuse and Misuse and other serious risks, and
the Medication Guide accompanying this piece or at
Nucynta.com/IRpi. Speak to your healthcare provider if you have
questions about Nucynta.
INDICATIONS AND USAGE
NUCYNTA® ER (tapentadol) is:
- A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage pain severe enough to require
daily, around-the-clock, long-term treatment with an opioid when
other pain treatments, such as non-opioid pain medicines or
immediate-release opioid medicines, do not treat your pain well
enough or you cannot tolerate them.
- Also used to manage pain from damaged nerves (neuropathic pain)
that happens with diabetes and is severe enough to require daily,
around-the-clock, long-term treatment with an opioid when other
pain treatments, such as non-opioid pain medicines, do not treat
your pain well enough or you cannot tolerate them.
- A long-acting (extended-release) opioid pain medicine that can
put you at risk for overdose and death. Even if you take your dose
correctly as prescribed, you are at risk for opioid addiction,
abuse, and misuse that can lead to death.
- Not used to treat pain that is not around-the-clock pain.
IMPORTANT SAFETY INFORMATION ABOUT NUCYNTA
ER
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; INTERACTION WITH ALCOHOL and RISKS FROM CONCOMITANT USE
WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTSAddiction, Abuse, and
MisuseNUCYNTA ER exposes patients and other users
to the risks of opioid addiction, abuse, and misuse, which can lead
to overdose and death. Assess each patient’s risk prior to
prescribing NUCYNTA ER, and monitor all patients regularly for the
development of these behaviors and
conditions.Opioid Analgesic Risk Evaluation and
Mitigation Strategy (REMS)To ensure that the
benefits of opioid analgesics outweigh the risks of addiction,
abuse, and misuse, the Food and Drug Administration (FDA) has
required a REMS for these products. Under the requirements of the
REMS, drug companies with approved opioid analgesic products must
make REMS-compliant education programs available to healthcare
providers. Healthcare providers are strongly encouraged to
- complete a REMS-compliant education
program,
- counsel patients and/or their caregivers, with every
prescription, on safe use, serious risks, storage, and disposal of
these products,
- emphasize to patients and their caregivers the
importance of reading the Medication Guide every time it is
provided by their pharmacist, and
- consider other tools to improve patient, household, and
community safety.
Life-Threatening Respiratory
DepressionSerious, life-threatening, or fatal
respiratory depression may occur with use of NUCYNTA ER. Monitor
for respiratory depression, especially during initiation of NUCYNTA
ER or following a dose increase. Instruct patients to swallow
NUCYNTA ER tablets whole; crushing, chewing, or dissolving NUCYNTA
ER tablets can cause rapid release and absorption of a potentially
fatal dose of tapentadol.Accidental
IngestionAccidental ingestion of even one dose of
NUCYNTA ER, especially by children, can result in a fatal overdose
of tapentadol.Neonatal Opioid Withdrawal
SyndromeProlonged use of NUCYNTA ER during
pregnancy can result in neonatal opioid withdrawal syndrome, which
may be life-threatening if not recognized and treated, and requires
management according to protocols developed by neonatology experts.
If opioid use is required for a prolonged period in a pregnant
woman, advise the patient of the risk of neonatal opioid withdrawal
syndrome and ensure that appropriate treatment will be
available.Interaction With
AlcoholInstruct patients not to consume alcoholic
beverages or use prescription or non-prescription products that
contain alcohol while taking NUCYNTA ER. The co-ingestion of
alcohol with NUCYNTA ER may result in increased plasma tapentadol
levels and a potentially fatal overdose of
tapentadol.Risks From Concomitant Use With
Benzodiazepines or Other CNS
DepressantsConcomitant use of opioids with
benzodiazepines or other central nervous system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death.
- Reserve concomitant prescribing of NUCYNTA ER and
benzodiazepines or other CNS depressants for use in patients for
whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum
required.
- Follow patients for signs and symptoms of respiratory
depression and sedation.
|
Important information about NUCYNTA ER:
- Get emergency help or call 911 right away if you take
too much NUCYNTA ER (overdose). When you first start
taking NUCYNTA ER, when your dose is changed, or if you take too
much (overdose), serious or life-threatening breathing problems
that can lead to death may occur. Talk to your healthcare provider
about naloxone, a medicine for the emergency treatment of an opioid
overdose.
- Taking NUCYNTA ER with other opioid medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including
street drugs) can cause severe drowsiness, decreased awareness,
breathing problems, coma, and death.
- Never give anyone your NUCYNTA ER. They could die from taking
it. Selling or giving away NUCYNTA ER Tablets is against the
law.
- Store NUCYNTA ER Tablets securely, out of sight and reach of
children, and in a location not accessible by others, including
visitors to the home.
Do not take NUCYNTA ER if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or
intestines.
Before taking NUCYNTA ER, tell your healthcare provider
if you have a history of:
- head injury, seizures
- problems urinating
- abuse of street or prescription drugs, alcohol addiction,
opioid overdose or mental health problems
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant.
Prolonged use of NUCYNTA ER during pregnancy can cause withdrawal
symptoms in your newborn baby that could be life-threatening if not
recognized and treated.
- breastfeeding. Not recommended during
treatment with NUCYNTA ER. It may harm your baby.
- living in a household where there are small children or someone
who has abused street or prescription drugs.
- taking prescription or over-the-counter medicines, vitamins, or
herbal supplements. Taking NUCYNTA ER with certain other medicines
can cause serious side effects.
When taking NUCYNTA ER:
- Do not change your dose. Take NUCYNTA ER exactly as prescribed
by your healthcare provider. Use the lowest effective dose for the
shortest time needed.Take your prescribed dose every 12 hours, at
the same time every day. Do not take more than your prescribed dose
in 24 hours. If you miss a dose, take your next dose at your usual
time
- Swallow NUCYNTA ER whole. Do not cut, break, chew, crush,
dissolve, snort, or inject NUCYNTA ER because this may cause you to
overdose and die.
- Call your healthcare provider if the dose you are
taking does not control your pain
- Do not stop taking NUCYNTA ER without talking to your
healthcare provider
- Dispose of expired, unwanted, or unused NUCYNTA ER Tablets by
promptly flushing down the toilet if a drug take-back option is not
readily available. Visit www.fda.gov/drugdisposal for
additional information on disposal of unused medicines.
While taking NUCYNTA ER DO NOT:
- Drive or operate heavy machinery until you know how NUCYNTA ER
affects you. NUCYNTA ER can make you sleepy, dizzy, or
lightheaded.
- Drink alcohol, or use prescription or over-the-counter
medicines containing alcohol. Using products containing alcohol
during treatment with NUCYNTA ER may cause you to overdose and
die.
The possible side effects of NUCYNTA ER
are:
- constipation, nausea, sleepiness, vomiting, tiredness,
headache, dizziness, abdominal pain. Call your healthcare provider
if you have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you
have:
- trouble breathing, shortness of breath, fast heartbeat, chest
pain, swelling of your face, tongue, or throat, extreme drowsiness,
light-headedness when changing positions, feeling faint, agitation,
high body temperature, trouble walking, stiff muscles, or mental
changes such as confusion.
- agitation, hallucinations, coma, feeling overheated, or heavy
sweating.
These are not all the possible side effects of NUCYNTA ER. Call
your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088. For more
information, go to dailymed.nlm.nih.gov.
See full Prescribing Information, including Boxed
Warning on Addiction, Abuse and Misuse and other serious risks, and
the Medication Guide accompanying this piece or at Nucynta.com/PI.
Speak to your healthcare provider if you have questions about
Nucynta ER.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. We may, in some cases, use terms such as
“predicts,” “forecasts,” “believes,” “potential,” “proposed,”
“continue,” “estimates,” “anticipates,” “expects,” “plans,”
“intends,” “may,” “could,” “might,” “should” or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. Examples of forward-looking statements
contained in this press release include, among others, statements
related to our pursuit of a pediatric extension of exclusivity for
the Nucynta franchise. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results, performance, or achievements to differ
materially from the company's current expectations, including the
risks described under the heading “Risk Factors” in our Annual
Reports on Form 10-K and Quarterly Reports on Form 10-Q and other
filings with the SEC. Any forward-looking statements that we
make in this press release speak only as of the date of this press
release. We assume no obligation to update our forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Investor Contact:Christopher
James, M.D.Vice President, Investor
Relationsir@collegiumpharma.com
Media Contact:Marissa
SamuelsVice President, Corporate Communications
communications@collegiumpharma.com
Collegium Pharmaceutical (NASDAQ:COLL)
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