Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives,
announced today that it will host a Commercial Day presentation to
provide an overview of its commercial strategy for recently
launched LUMRYZ on Thursday, June 29, 2023 beginning at 8:00 a.m.
ET. LUMRYZ was approved by the U.S. Food & Drug Administration
(FDA) in May 2023 for the treatment of cataplexy or excessive
daytime sleepiness (EDS) in adults with narcolepsy.
Greg Divis, Chief Executive Officer,
Richard Kim, Chief Commercial Officer, and
Jennifer Gudeman, Senior Vice President of Medical
and Clinical Affairs, will be joined by renowned sleep specialists
to discuss sleep medicine insights, treatment perspectives, market
opportunities, and commercial strategy. Additionally, a person with
narcolepsy, currently taking LUMRYZ, will also participate and
discuss her experience with LUMRYZ.
Renowned sleep specialists will include:
- Dr. Anne Marie Morse, D.O., FAASM:Dr. Anne
Marie Morse is a board-certified neurologist and trained sleep
medicine specialist. She is the Director of Child Neurology and
Pediatric Sleep Medicine at Janet Weis Children’s Hospital –
Geisinger Health System, and is a recognized key opinion leader in
sleep medicine, especially with regard to central disorders of
hypersomnolence, such as narcolepsy and idiopathic
hypersomnia.
- Dr. Thomas Stern, M.D., M.S., FAASM, FCCP:Dr.
Thomas Stern completed board certification in five different
medical specialties including internal medicine, pediatrics,
pulmonary medicine, critical care medicine and sleep medicine. He
has a Master’s degree in clinical research. He founded Advanced
Respiratory and Sleep Medicine, PLLC in Huntersville, NC in 2009
where he manages chronic pulmonary and sleep disorders and conducts
clinical trials for new treatments in these areas.
To access the live audio webcast of the event, please register
here. A live audio webcast of the event and accompanying slide
presentation will also be available in 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.
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.
About LUMRYZ™ (sodium oxybate) for extended-release oral
suspension, CIII
LUMRYZ, is an extended-release sodium oxybate medication
approved by the FDA on May 1, 2023, as the first and only
once-at-bedtime oxybate 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 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.
Investor Contact:Courtney TurianoStern Investor
Relations, Inc. Courtney.Turiano@sternir.com (212) 698-8687
Media Contact:Natalie RubinoReal
Chemistrynrubino@realchemistry.com
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