Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives,
announced today that the first patient has been dosed in REVITALYZ,
a Phase 3 study evaluating LUMRYZ as a potential treatment for
idiopathic hypersomnia (IH).
"IH is a debilitating sleep disorder characterized
by profound sleep inertia, or difficulty waking up and persistent
profound daytime sleepiness. Awareness and diagnosis of IH has
increased markedly over the last several years. However, IH
patients are severely limited in effective treatment options,
representing a large unmet need,” said Richard K. Bogan, MD,
FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC, and
Associate Clinical Professor at University of South Carolina School
of Medicine. "The potential of LUMRYZ to treat IH with only a
single bedtime dose of extended-release sodium oxybate is
promising, and the initiation of the Phase 3 REVITALYZ study marks
a significant step toward improving care for those living with
IH.”
REVITALYZ is a double-blind, placebo-controlled,
randomized withdrawal, multicenter Phase 3 study designed to
evaluate the efficacy and safety of LUMRYZ given as a
once-at-bedtime dose, in IH. The study will enroll approximately
150 adults who are diagnosed with IH and includes an open label
extension portion. REVITALYZ enrollment is open for both
participants switching from immediate-release oxybates and not
currently taking oxybates.
The primary objective of REVITALYZ is to
demonstrate reduction in daytime sleepiness as measured by the
primary endpoint, change in total score of the Epworth Sleepiness
Scale (ESS) at Week 14. Secondary endpoints will evaluate the
effect of LUMRYZ on additional efficacy parameters including
patient and clinician impression of change, idiopathic hypersomnia
severity, and a measure of the functional outcomes of sleep.
“Dosing the first patient in REVITALYZ is an
important milestone for the IH community, which has been vocal in
the need for more treatment options, particularly an
extended-release form of oxybate that would ideally provide full
nocturnal drug exposure in a single, once-at-bedtime dose,” stated
Jennifer Gudeman, PharmD, Senior Vice President, Medical and
Clinical Affairs of Avadel Pharmaceuticals. “We are committed to
advancing this study and are emboldened by the excitement of
experienced clinical trial sites’ participation, which reflects the
critical unmet need in the current therapeutic landscape.”
Additional information about the trial can be found
at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier:
NCT06525077).
About LUMRYZ™ (sodium oxybate) for
extended-release oral suspension
LUMRYZ 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 Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is a rare sleep
disorder characterized by excessive daytime sleepiness (EDS) not
attributable to any other medical conditions or symptom of another
medical condition. Symptoms may include prolonged nocturnal sleep
of good quality, difficulty in waking up, and brain fog. Additional
symptoms may include falling asleep unintentionally, challenges in
maintaining focus, and occasional memory lapses. IH can have a
significant impact on a patient’s quality of life. According to
claims data, there are an estimated 37,000 diagnosed IH patients in
the United States, although the total patient population may be
greater due to some patients who have not yet been diagnosed, have
been misdiagnosed, or are not currently seeking treatment.
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. 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.
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 and
market preference for LUMRYZ in idiopathic hypersomnia, if
approved; the progress, timing and success of the Phase 3 REVITALYZ
trial, including expectations for trial design and enrollment; and
statements regarding the results and analysis of Avadel’s trials
and studies including the details and content thereof. 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, 2023, which was filed with
the Securities and Exchange Commission (SEC)
on February 29, 2024, 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
MogerleyPrecision AQCourtney.Mogerley@precisionaq.com(212)
698-8687
Media Contact:Lesley StanleyReal
Chemistrylestanley@realchemistry.com(609) 273-3162
Avadel Pharmaceuticals (NASDAQ:AVDL)
過去 株価チャート
から 7 2024 まで 8 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
過去 株価チャート
から 8 2023 まで 8 2024