Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives,
announced today that the U.S. Food & Drug Administration (FDA)
has granted final approval to LUMRYZ, an extended-release
formulation of sodium oxybate indicated to be taken once at bedtime
for the treatment of cataplexy or excessive daytime sleepiness
(EDS) in adults with narcolepsy. With final approval, LUMRYZ
becomes the first and only FDA approved once-at-bedtime oxybate for
people living with narcolepsy. LUMRYZ was additionally granted
Orphan Drug Exclusivity by the FDA.
“Today’s landmark approval and receipt of Orphan Drug
Exclusivity represents a major milestone for both Avadel and people
living with narcolepsy. As we have heard from key stakeholders,
previously approved narcolepsy therapies have the potential to
disrupt sleep by either causing insomnia or through forced
awakening during the middle of the night for their crucial second
dose. LUMRYZ can now offer people with narcolepsy the opportunity
for an uninterrupted night sleep while receiving the full benefit
of their prescribed treatment in one single bedtime dose that
addresses their symptoms of narcolepsy,” said Greg Divis, Chief
Executive Officer of Avadel. “We would like to thank the patients,
caregivers, clinical trial investigators, healthcare providers, and
advocates who have tirelessly partnered with us throughout the drug
development process and look forward to providing the narcolepsy
community access to now approved LUMRYZ.”
Narcolepsy is a chronic neurological condition that impairs the
brain's ability to regulate the sleep-wake cycle. The condition
affects approximately one in 2,000 people in the United States with
the cardinal symptom of EDS. Additional symptoms can vary by person
but may include disrupted nighttime sleep, a sudden loss of muscle
tone usually triggered by strong emotion (cataplexy), sleep
paralysis and hallucinations.
“This long-awaited therapy for people living with narcolepsy
fills a critical unmet need by avoiding the burden of a second
middle-of-the-night dose that immediate-release oxybate products
require. The once-at-bedtime dosing regimen of LUMRYZ may help
restore a more natural sleep-wake cycle,” said Michael J. Thorpy,
M.D., an investigator from the REST-ON Phase 3 trial and Director
at the Sleep-Wake Disorders Center at Montefiore Medical Center and
Professor of Neurology at the Albert Einstein College of
Medicine.
The FDA’s final approval of LUMRYZ was based on positive results
from the pivotal Phase 3 REST-ON clinical study completed in March
2020. In the REST-ON Phase 3 trial, once-at-bedtime LUMRYZ
demonstrated highly statistically significant (p<0.001) and
clinically meaningful improvement compared to placebo across all
three co-primary endpoints (Maintenance of Wakefulness Test,
Clinical Global Impression-Improvement and mean weekly cataplexy
attacks) for all three doses evaluated, 6, 7.5 and 9 grams.
With this approval, the FDA has also found LUMRYZ to be
clinically superior to currently marketed twice-nightly oxybate
products and granted LUMRYZ seven years of Orphan Drug Exclusivity.
In particular, FDA found that LUMRYZ makes a major contribution to
patient care over currently available, twice-nightly oxybate
products by providing a once-nightly dosing regimen that avoids
nocturnal arousal to take a second dose. The FDA's Orphan Drug
program is designed to support the development of drugs that treat
a condition affecting less than 200,000 U.S. patients. The
seven-year market exclusivity for LUMRYZ began on the date of FDA
approval, May 1, 2023.
“For people living with narcolepsy, and for all of us who
advocate for this community, the approval of LUMRYZ is an important
step forward,” said Julie Flygare, JD, President and CEO of Project
Sleep. “People living with narcolepsy will finally have a new
treatment option to manage EDS and cataplexy, and the fact that
this new oxybate option allows for reduced dosing frequency is a
game-changing advancement that shows Avadel’s commitment to
understanding the patient experience. We look forward to continued
collaboration with Avadel as part of a shared mission to positively
impact the lives of people with narcolepsy.”
LUMRYZ has a boxed warning as a central nervous system
depressant, and for its potential for abuse and misuse. LUMRYZ is
available only through a restricted program under a Risk Evaluation
and Mitigation Strategy called the LUMRYZ REMS. Most common adverse
reactions (incidence > 5% and greater than placebo) reported for
all doses of LUMRYZ combined were nausea, dizziness, enuresis,
headache, and vomiting.
Conference CallA live audio webcast of the call
can be accessed by visiting the investor relations section of the
Company’s website, www.avadel.com. A replay of the webcast will be
archived on Avadel’s website for 90 days following the event.
Participants may register for the conference call here and are
advised to do so at least 10 minutes prior to joining the call.
About LUMRYZ™ (sodium
oxybate) for extended-release oral suspensionLUMRYZ, is an
extended-release sodium oxybate medication approved by the FDA on
May 1, 2023, as the first and only once-at-bedtime treatment for
cataplexy or excessive daytime sleepiness (EDS) in adults with
narcolepsy. The FDA approval of LUMRYZ was supported by results
from REST-ON, a randomized, double-blind, placebo-controlled,
pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ
demonstrated statistically significant and clinically meaningful
improvements in the three co-primary endpoints: EDS, clinicians’
overall assessment of patients’ functioning (CGI-I), and cataplexy
attacks, for all three evaluated doses when compared to placebo.
With its approval, the FDA also granted seven years of Orphan
Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in
adults with narcolepsy due to a finding of clinical superiority of
LUMRYZ relative to currently available oxybate treatments. In
particular, the FDA found that LUMRYZ makes a major contribution to
patient care over currently available, twice-nightly oxybate
products by providing a once-nightly dosing regimen that avoids
nocturnal arousal to take a second dose.
About Avadel Pharmaceuticals plcAvadel
Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company
focused on transforming medicines to transform lives. Our approach
includes applying innovative solutions to the development of
medications that address the challenges patients face with current
treatment options. Avadel’s commercial product, LUMRYZ, was
approved by the U.S. Food & Drug Administration (FDA) as the
first and only once-at-bedtime oxybate for the treatment of
cataplexy or excessive daytime sleepiness (EDS) in adults with
narcolepsy. For more information, please visit
www.avadel.com.
IMPORTANT SAFETY INFORMATION
WARNING: Taking LUMRYZ™ (sodium oxybate) with other central
nervous system (CNS) depressants such as medicines used to make you
fall asleep, including opioid analgesics, benzodiazepines, sedating
antidepressants, antipsychotics, sedating anti-epileptic medicines,
general anesthetics, muscle relaxants, alcohol, or street drugs,
may cause serious medical problems, including trouble breathing
(respiratory depression), low blood pressure (hypotension), changes
in alertness (drowsiness), fainting (syncope), and
death.The active ingredient of LUMRYZ (sodium
oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled
substance. Abuse or misuse of illegal GHB alone or with other CNS
depressants (drugs that cause changes in alertness or
consciousness) have caused serious side effects. These effects
include seizures, trouble breathing (respiratory depression),
changes in alertness (drowsiness), coma, and death. Call your
doctor right away if you have any of these serious side
effects.Because of these risks, LUMRYZ is
available only by prescription and filled through certified
pharmacies in the LUMRYZ REMS program. You must be enrolled in the
LUMRYZ REMS to receive LUMRYZ. Further information is available
at www.LUMRYZREMS.com or by
calling 1-877-453-1029. |
INDICATIONSLUMRYZ (sodium oxybate) for
extended-release oral suspension is a prescription medicine used to
treat the following symptoms in adults with narcolepsy:
- sudden onset of weak or paralyzed muscles (cataplexy)
- excessive daytime sleepiness (EDS)
It is not known if LUMRYZ is safe and effective in people less
than 18 years of age.
Do not take LUMRYZ if you take other sleep
medicines or sedatives (medicines that cause sleepiness), drink
alcohol, or have a rare problem called succinic semialdehyde
dehydrogenase deficiency.
Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling
or giving away LUMRYZ may harm others and is against the law. Tell
your doctor if you have ever abused or been dependent on alcohol,
prescription medicines, or street drugs.
Anyone who takes LUMRYZ should not do anything that requires
them to be fully awake or is dangerous, including driving a car,
using heavy machinery, or flying an airplane, for at least six (6)
hours after taking LUMRYZ. Those activities should not be done
until you know how LUMRYZ affects you.
Falling asleep quickly, including while standing or while
getting up from the bed, has led to falls with injuries that have
required some people to be hospitalized.
LUMRYZ can cause serious side effects, including the
following:
- Breathing problems, including slower
breathing, trouble breathing, and/or short periods of not breathing
while sleeping (eg, sleep apnea). People who already have breathing
or lung problems have a higher chance of having breathing problems
when they take LUMRYZ.
- Mental health problems,
including confusion, seeing or hearing things that
are not real (hallucinations), unusual or disturbing thoughts
(abnormal thinking), feeling anxious or upset, depression, thoughts
of killing yourself or trying to kill yourself, increased
tiredness, feelings of guilt or worthlessness, and difficulty
concentrating. Tell your doctor if you have or had depression or
have tried to harm yourself. Call your doctor right
away if you have symptoms of mental health problems or a change in
weight or appetite.
- Sleepwalking. Sleepwalking can cause
injuries. Call your doctor if you start sleepwalking.
Tell your doctor if you are on a salt-restricted diet or if you
have high blood pressure, heart failure, or kidney problems. LUMRYZ
contains a lot of sodium (salt) and may not be right for you.
The most common side effects of LUMRYZ in adults include nausea,
dizziness, bedwetting, headache, and vomiting. Your side effects
may increase when you take higher doses of LUMRYZ. LUMRYZ can cause
physical dependence and craving for the medicine when it is not
taken as directed. These are not all the possible side effects of
LUMRYZ.
For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side
effects.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
Please see full Prescribing
Information, including BOXED Warning.
Cautionary Disclosure Regarding Forward-Looking
StatementsThis press release includes “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.
These forward-looking statements relate to our future expectations,
beliefs, plans, strategies, objectives, results, conditions,
financial performance, prospects, or other events. Such
forward-looking statements include, but are not limited to,
expectations regarding the potential therapeutic benefit of LUMRYZ;
the Orphan Drug Exclusivity for LUMRYZ and potential benefits
resulting from such designation; the preparation and timing of
commercial launch and the success of such commercialization for
LUMRYZ; expectations regarding the potential market impact of
LUMRYZ; and the anticipated market availability of LUMRYZ. In some
cases, forward-looking statements can be identified by the use of
words such as “will,” “may,” “could,” “believe,” “expect,” “look
forward,” “on track,” “guidance,” “anticipate,” “estimate,”
“project,” “next steps” and similar expressions, and the negatives
thereof (if applicable).
The Company’s forward-looking statements are based on estimates
and assumptions that are made within the bounds of our knowledge of
our business and operations and that we consider reasonable.
However, the Company’s business and operations are subject to
significant risks, and, as a result, there can be no assurance that
actual results and the results of the company’s business and
operations will not differ materially from the results contemplated
in such forward-looking statements. Factors that could cause actual
results to differ from expectations in the Company’s
forward-looking statements include the risks and uncertainties
described in the “Risk Factors” section of Part I, Item 1A of the
Company’s Annual Report on Form 10-K for the year ended December
31, 2022, which was filed with the Securities and Exchange
Commission (SEC) on March 29, 2023, and subsequent SEC filings.
Forward-looking statements speak only as of the date they are
made and are not guarantees of future performance. Accordingly, you
should not place undue reliance on forward-looking statements. The
Company does not undertake any obligation to publicly update or
revise our forward-looking statements, except as required by
law.
Investor Contact:Courtney TurianoStern Investor
Relations, Inc. Courtney.Turiano@sternir.com (212) 698-8687
Media Contact:Gabriella GreigReal
Chemistryggreig@realchemistry.com (203) 249-2688
Avadel Pharmaceuticals (NASDAQ:AVDL)
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부터 6월(6) 2024 으로 7월(7) 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
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부터 7월(7) 2023 으로 7월(7) 2024