Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives, today
announced the publication of results of a post-hoc analysis from
the completed pivotal Phase 3 REST-ON clinical trial demonstrating
greater weight loss in patients who received LUMRYZ compared with
placebo. The paper, titled “Weight Loss With Once-nightly Sodium
Oxybate for the Treatment of Narcolepsy: Analysis From the Phase
III Randomized study Evaluating the efficacy and SafeTy of a ONce
nightly formulation of sodium oxybate (REST-ON) Trial,” was
published online in Clinical Therapeutics.
“Obesity is a struggle for many people, and it is very common in
patients with narcolepsy,” said Asim Roy, M.D., co-author of the
paper and Medical Director of the Ohio Sleep Medicine Institute.
“Obesity is an important modifiable risk factor for cardiovascular
diseases. These new data show that LUMRYZ use was associated with a
reduction in body mass index and weight during the 13-week trial.
While all REST-ON participants, including both narcolepsy Type 1
(with cataplexy) and narcolepsy Type 2 (without cataplexy) showed
improvement in core narcolepsy symptoms (i.e., excessive daytime
sleepiness and cataplexy), this improvement was even more
pronounced in the subgroup experiencing a ≥5% weight loss.”
REST-ON is a randomized, double-blind, placebo-controlled,
pivotal Phase 3 trial evaluating once-at-bedtime LUMRYZ in adults
with narcolepsy. Weight and body mass index (BMI) were measured at
baseline and at the end of the study. The mean age of the study
participants was 31.2 years, 67.9% were women and 75.5% were white.
Among those treated with LUMRYZ (n=107), 67.5% and 37.0% of
participants with narcolepsy type 1 (NT1) and narcolepsy type 2
(NT2), respectively, were overweight or obese at baseline, as were
69.5% and 61.0%, respectively, of those in the placebo group
(n=105). Mean weight at baseline was similar between the LUMRYZ and
placebo groups (81.2 kg and 82.1 kg, respectively).
“Given the high rates of obesity in the U.S, and its associated
cardiometabolic risks, we were encouraged to see that nearly one in
five study participants treated with LUMRYZ experienced clinically
meaningful weight loss,” said Jennifer Gudeman, Pharm.D.,
Senior Vice President, Medical and Clinical Affairs of Avadel.
“These findings suggest that LUMRYZ, given its proven benefit in
reducing cataplexy and EDS, as well its once-at-bedtime dosing,
which provides the opportunity for an uninterrupted night sleep,
has the potential to provide a more tailored treatment approach for
people with narcolepsy who are overweight or living with
obesity.”
Results of the post-hoc analysis, which evaluated the effect of
LUMRYZ treatment on weight in adults with narcolepsy and further
characterized participants experiencing >5% weight loss,
showed:
- Participants who received LUMRYZ lost a mean of 1.3 kg from
baseline to week 13. In contrast, those receiving placebo
experienced a mean weight gain of 0.2 kg.
- A significantly higher proportion of study participants
receiving LUMRYZ experienced ≥5% weight loss than those who
received placebo (17.8% versus 3.8%; p=0.001).
- A significant reduction in BMI was observed after 13 weeks of
treatment with LUMRYZ versus placebo, with a between-group
difference in least squares mean change from baseline of −0.59
kg/m2 (p=0.001).
- In the weight loss group, participants shifted from obese into
overweight, and from overweight into normal weight during this
trial; no participants were underweight.
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.
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.
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.
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
in treating narcolepsy-related EDS or cataplexy, including
potential impact on patient weight; and the results and analysis of
the Phase 3 REST-ON trial, 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 8 2024 まで 9 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
過去 株価チャート
から 9 2023 まで 9 2024