Avadel Pharmaceuticals plc (NASDAQ:AVDL), announced that data for
the clinical evaluation of Noctiva (previously “SER120”) for the
treatment of patients with nocturia due to nocturnal polyuria with
concomitant overactive bladder (OAB) will be presented in an oral
poster presentation at Pelvic Floor Disorders (PFD) Week 2017, the
American Urogynecologic Society’s annual scientific meeting.
Douglas Van Drie, M.D., who specializes in
urogynecology and reconstructive pelvic surgery, will present oral
poster 127, “Evaluation of SER120 for the Treatment of Patients
with Nocturia due to Nocturnal Polyuria with Concomitant Overactive
Bladder,” authored by Van Drie, D., Lepor, H., Nitti, V., Cheng,
M., Cheng, L., Fein, S., on Friday, Oct. 6 at 5:11 p.m. EST at the
Rhode Island Convention Center in Providence, R.I.
“Nocturia is a medical condition that affects
approximately 40 million people in the United States and represents
an unmet medical need among my urogynecological patients,”
commented Van Drie. “The condition results in frequent nighttime
urination, which prevents patients from experiencing a normal,
restful sleep cycle and can lead to a number of complex and costly
co-morbidities and health-related consequences, such as nighttime
falls and fractures, impaired daytime functioning and productivity,
and compromised quality of life.”
In an subset analysis of Noctiva’s Phase III
pivotal studies, 207 patients suffering from nocturia due to
nocturnal polyuria with concomitant overactive bladder were
evaluated. Patients on Noctiva demonstrated both a significant
reduction in mean number of nocturic episodes, a significant
improvement to their overall quality of life and a substantial
increase in the time from bedtime to first nocturic void compared
to placebo.
Noctiva at doses of 1.66 and 0.83 mcg is
effective for the treatment of patients with nocturia due to
nocturnal polyuria with concomitant OAB. Highlights of Dr. Van
Drie’s presentation at Friday’s event will include:
• The reduction in mean nocturic episodes/night for the
1.66 mcg dose was 2 times that of placebo (P=.0010) and almost 2
times that of placebo for the 0.83 mcg dose (P=.0076)
• The percentage of patients who achieved ≥50% reduction in
mean nocturic nocturic episodes/night for the 1.66 mcg dose was
more than 3 times greater than placebo (P=.0007) and 0.83 mcg dose
was >2.5 times that of placebo (P=.0096)
• The validated QoL Questionnaire (INTU) completed by the
patients demonstrated an almost 6 times greater improvement in the
QoL for the 1.66 mcg dose and approximately 5 times greater
improvement for the 0.83 mcg dose compared to placebo. These
results documented that decreasing nocturic episodes correlated
with clinically meaningful improvements in how these patients felt
and functioned
• The length of time from bedtime to first nocturic void
was 2.4 times greater than placebo for the 1.66 mcg dose (P=.0136)
and 2.8 times great than placebo for the 0.83 mcg dose
(P=.0036)
About Noctiva™Noctiva is the
first and only formulation of desmopressin acetate, a vasopressin
analog, approved by the FDA for the treatment of nocturia due to
nocturnal polyuria in adults who awaken at least two times per
night to void. It is a proprietary low-dose formulation of
desmopressin acetate administered through a patent-protected
preservative-free intranasal delivery system. Its nasal
administration provides targeted absorption, a consistent
pharmacokinetic profile and excellent bioavailability.* Noctiva is
dosed as a single spray in one nostril 30 minutes before bedtime,
and is approved in two dosage forms of 0.83 mcg and 1.66 mcg.
Noctiva is expected to become available to patients in the second
quarter of 2018. (Full Prescribing Information
available here).
Important Safety Information and
Indication for Noctiva (desmopressin acetate)
*Data on file
WARNING: HYPONATREMIA
Call 1-877-622-2320 for a complete list of
warnings.
• NOCTIVA can cause hyponatremia, which is a condition
that occurs when you do not have enough sodium in your
blood.
• Your doctor should monitor the sodium levels in
your blood before you start and while you are using NOCTIVA. Mild
cases of hyponatremia may not have any symptoms, but signs can
include nausea, vomiting, fatigue, dizziness, headache, confusion,
muscle cramps, feeling restless, and in severe cases, seizures and
coma. It may be life-threatening if severe.
• Some people should not take NOCTIVA because of a
higher risk of severe hyponatremia. You should not take NOCTIVA if
you have a lot of fluid intake, have an illness that can cause
fluid or electrolyte imbalances, or use loop diuretics (water pills
like bumetanide or ethacrynic acid) or systemic or inhaled
glucocorticoids (steroids like cortisone or
prednisone).
• You may need to temporarily or permanently stop
taking NOCTIVA if you get hyponatremia.
What is NOCTIVA used
for?NOCTIVA is a prescription medicine nasal (nose) spray
used in adults who wake up two or more times during the night to
urinate due to a condition called nocturnal polyuria. Nocturnal
polyuria is a condition where your body makes too much urine at
night. There are other conditions that could cause you to wake up
during the night to urinate. NOCTIVA is only approved for the
treatment of nocturnal polyuria. Your doctor should have you
measure your urine and the times that you urinate for 24 hours to
determine if you have nocturnal polyuria if you have not already
done this.
NOCTIVA is not intended for use in
children. It has not been studied in adults less than 50
years old, so it is unknown whether NOCTIVA is safe or effective in
people below this age.
Who should not take NOCTIVA?You
should not take NOCTIVA if you:
• have or have had low salt levels in your blood
• are thirsty much of the time and drink large amounts of
fluids (polydipsia)
• wet the bed while sleeping at night
• are taking a type of water-pill called a
loop-diuretic
• are taking a glucocorticoid (steroid) medicine, including
an inhaled glucocorticoid (steroid) medicine
• have moderate to severe kidney problems
• have or may have a condition called syndrome of
inappropriate antidiuretic hormone (SIADH) secretion
• have an illness that can cause you to have low levels of
fluid or electrolytes in your blood, such as vomiting, diarrhea, an
infection, or a kidney problem that causes you to lose too much
salt
• have symptoms from a heart problem called congestive
heart failure
• have high blood pressure that is not controlled
Ask your doctor if you are not sure you
have any of these conditions or take any of the types of medicines
listed.
What is the most important information
you should know about NOCTIVA?
NOCTIVA can cause hyponatremia (low
levels of sodium in the blood). Severe cases can lead to
seizures, coma, or death. It can cause fluid retention (water
weight gain), which can be a particular problem for people with
congestive heart failure or uncontrolled high blood pressure.
Call your doctor if you have any of the
following symptoms of low salt levels in your blood:
• headache
• nausea or vomiting
• drowsiness
• dizziness
• muscle cramps
• feeling restless
• fatigue
• change in your mental condition, such as
confusion, or decreased awareness or alertness
Low salt levels in the blood happen more often
in people treated with NOCTIVA who are 65 years old or older than
in people treated with NOCTIVA who are younger than 65 years old.
Your doctor should check the salt levels in your blood before you
start or re-start taking NOCTIVA, during treatment with NOCTIVA,
and before increasing your dose.
Ask your doctor if you should temporarily
discontinue NOCTIVA if you have allergies or a cold that makes your
nose runny or stuffed up, as having such symptoms could affect how
your body absorbs the medicine in NOCTIVA.
What should you tell your health care
provider?
Before using NOCTIVA, tell your health care
provider about all of your medical conditions, including if
you:
• have vomiting, diarrhea, fever, or infection
• have kidney or heart problems
• have diabetes mellitus
• have had a head injury
• have a heart problem called congestive heart failure
• have a history of not being able to empty your bladder
all of the way (urinary retention)
• have any nose problems, such as blockage, stuffy nose,
runny nose, or drainage
• are pregnant or plan to become pregnant. It is not known
if NOCTIVA can harm your unborn baby.
• Are breastfeeding or plan to breastfeed. Desmopressin,
and ingredient in NOCTIVA, passes into breast milk. Talk to your
doctor about the best way to feed your baby if you use NOCTIVA.
Tell your doctor about all the medicines
you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. Using
NOCTIVA with certain other medicines may cause serious side
effects. Do not start taking any new medicines until you talk to
your doctor.
Especially tell your doctor if you take
a:
• water pill (diuretic)
• glucocorticoid (steroid) medicine, including an inhaled
glucocorticoid (steroid) medicine
- Your doctor should stop your treatment with NOCTIVA for a
period of time while you are taking and after you stop taking an
oral or inhaled glucocorticoid (steroid) medicine.
• medicine used to treat depression called a tricyclic
antidepressant or selective serotonin reuptake inhibitor (SSRI)
• medicine used to treat mood disorders, such as
schizophrenia or bipolar disorder called chlorpromazine
• medicine used to treat seizures, nerve pain, or bipolar
disorder called carbamazepine
• non-steroidal anti-inflammatory medicine (NSAID)
• medicine that you use in your nose
There have not been any studies done to see if
other medicines might interact with NOCTIVA. Ask your
doctor or pharmacist if you are not sure if your medicine is one of
the types listed above, or if you are unsure whether any
of the medicines you already take might put you at increased risk
of side effects.
How should you take NOCTIVA?You
should use NOCTIVA exactly as instructed by your health care
professional. Your doctor has prescribed the strength that is
best for you, and you should not use more than 1 spray of the
prescribed dose at a time, even if you missed a prior dose.
What are the side effects of
NOCTIVA?NOCTIVA may cause serious side effects, including
hyponatremia, which may lead to serious or life-threatening
conditons, including seizure, coma, trouble breathing, or death if
not treated early. NOCTIVA may also cause your body to hold too
much water (fluid retention).The most common side effects of
NOCTIVA include:
• nose discomfort
• pain or swelling (inflammation) in your nose or
throat
• stuffy nose
• sneezing
• high blood pressure
• back pain
• nosebleed
• inflammation of the lining of the bronchial tubes that
carry air to and from your lungs that causes a cough
(bronchitis)
• dizziness
These are not all of the possible side effects
of NOCTIVA. You are encouraged to call your doctor for
medical advice about side effects, and you can also report them to
the FDA.
To report SUSPECTED SIDE EFFECTS,
contact Avadel Specialty Pharmaceuticals, LLC, at 1-877-622-2320 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please be aware that this is not a
complete listing of all safety information associated with NOCTIVA.
For more information, call 1-877-622-2320.
About Avadel Pharmaceuticals
plc: Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a
specialty pharmaceutical company that seeks to commercialize
differentiated pharmaceutical products that are safe, effective and
easy to take through formulation development, by utilizing its
proprietary drug delivery technology and in-licensing / acquiring
new products; ultimately, helping patients adhere to their
prescribed medical treatment and see better results. The Company is
headquartered in Dublin, Ireland with operations in St. Louis,
Missouri and Lyon, France. For more information, please visit
www.avadel.com.
Safe Harbor
This press release may include forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934. The
words “will,” “may,” “believe,” “expect,” “anticipate,” “estimate,”
“project” and similar expressions, and the negatives thereof,
identify forward-looking statements, each of which speaks only as
of the date the statement is made. Although we believe that our
forward-looking statements are based on reasonable assumptions
within the bounds of our knowledge of our business and operations,
our business is subject to significant risks and as a result there
can be no assurance that actual results of our research,
development and commercialization activities and our results of
operations will not differ materially from the results contemplated
in such forward-looking statements. These risks include: (i) risks
relating to our license agreement with Serenity Pharmaceuticals,
LLC including that our internal analyses may overstate the market
opportunity in the United States and Canada for the drug
desmopressin acetate (the “Drug”) or we may not effectively exploit
such market opportunity, that significant safety or drug
interaction problems could arise with respect to the Drug, that we
may not successfully increase awareness of nocturia and the
potential benefits of the Drug, and that the need for management to
focus attention on the development and commercialization of the
Drug could cause our ongoing business operations to suffer; and
(ii) the other risks, uncertainties and contingencies described in
the Company's filings with the U.S. Securities and Exchange
Commission, including our annual report on Form 10-K for the year
ended December 31, 2016, in particular under the captions
“Forward-Looking Statements” and “Risk Factors,” including without
limitation: our dependence on a small number of products and
customers for the majority of our revenues; the possibility that
our Bloxiverz®,Vazculep® and Akovaz® products, which are not patent
protected, could face substantial competition resulting in a loss
of market share or forcing us to reduce the prices we charge for
those products; the possibility that we could fail to successfully
complete the research and development for pipeline products we are
evaluating for potential application to the FDA pursuant to our
"unapproved-to-approved" strategy, or that competitors could
complete the development of such products and apply for FDA
approval of such products before us; the possibility that our
products may not reach the commercial market or gain market
acceptance; our need to invest substantial sums in research and
development in order to remain competitive; our dependence on
certain single providers for development of several of our drug
delivery platforms and products; our dependence on a limited number
of suppliers to manufacture our products and to deliver certain raw
materials used in our products; the possibility that our
competitors may develop and market technologies or products that
are more effective or safer than ours, or obtain regulatory
approval and market such technologies or products before we do; the
challenges in protecting the intellectual property underlying our
drug delivery platforms and other products; and our dependence on
key personnel to execute our business plan. Except as may be
required by law, we disclaim any obligation to publicly update any
forward-looking statements to reflect events after the date of this
press release.
Contacts
Media:Alli
WentlingFleishmanHillardPhone: (314)
986-6295Email: alli.wentling@fleishman.com
Investors:Mike
KananAvadelPhone: (636) 449-1844Email:
mkanan@avadel.com
Lauren StivalAvadelPhone:
(636) 449-5866Email: lstival@avadel.com
Avadel Pharmaceuticals (NASDAQ:AVDL)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024