Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives,
announced today that LUMRYZ is now commercially available. LUMRYZ
is 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.
“We are proud to announce that LUMRYZ is commercially available
through both our RYZUP™ patient support program and our specialty
pharmacy network for patients living with narcolepsy who have been
waiting for over two decades for a single dose treatment option
that provides the opportunity for an uninterrupted night sleep,”
said Greg Divis, Chief Executive Officer of Avadel. “LUMRYZ
represents a new generation of oxybate treatment the FDA deemed
clinically superior to all twice nightly oxybate treatments. The
Avadel team is fully prepared to execute our commercial strategy
and deliver LUMRYZ to the $3 billion plus once-at-bedtime oxybate
market.”
LUMRYZ is the first and only U.S. Food & Drug Administration
(FDA) approved once-at-bedtime oxybate for people living with
narcolepsy. The commercial strategy for LUMRYZ includes an
extensive patient support program, RYZUP, which is designed to
provide support and education to patients who have been prescribed
LUMRYZ and to assist them in gaining access to their medication.
More information about the RYZUP patient support program can be
accessed at ryzupsupport.com.
LUMRYZ was granted FDA approval 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.
LUMRYZ was approved by the FDA on May 1 and was granted a seven
year period of Orphan Drug Exclusivity as a result of the FDA
finding LUMRYZ to be clinically superior to all first generation
oxybate products. 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.
About Avadel Pharmaceuticals plc
Avadel 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 (e.g., 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, and Medication Guide.
Cautionary Disclosure Regarding Forward-Looking
Statements
This 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;
expectations regarding the commercial availability of LUMRYZ;
expectations regarding the potential benefits of the RYZUP patient
support program; and expectations regarding the potential market
opportunity and market impact 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
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