Avadel Pharmaceuticals plc (Nasdaq: AVDL), today issued a statement
in response to a jury ruling from the United States District Court
for the District of Delaware (“Court”) in a patent suit brought by
Jazz Pharmaceuticals Inc. regarding LUMRYZ™.
Avadel is pleased with the jury’s decision ruling in favor of
Avadel with respect to one of the contested patents. As it relates
to the jury’s decision against Avadel regarding the additional
contested patent, the company is disappointed in the outcome.
Avadel will vigorously defend its position with the pursuit of all
options, including an appeal, to overturn the unfavorable aspect of
the jury’s decision upon final entry of the decision by the
Court.
Avadel does not expect the jury’s decision to impact the ongoing
commercial launch or potential for LUMRYZ™ to transform the lives
of people living with narcolepsy.
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 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. 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 outcome of the litigation involving Jazz
Pharmaceuticals Inc.; Avadel’s intent to pursue options to overturn
certain aspects of the jury’s decision; and the potential
disruption or adverse effect on the launch efforts for 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, 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 MogerleyStern
Investor Relations, Inc.Courtney.Mogerley@sternir.com (212)
698-8687
Media Contact:Lesley StanleyReal
Chemistrylestanley@realchemistry.com(609) 273-3162
Avadel Pharmaceuticals (NASDAQ:AVDL)
Gráfico Histórico do Ativo
De Ago 2024 até Set 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
Gráfico Histórico do Ativo
De Set 2023 até Set 2024