Avadel Recognizes World Narcolepsy Day and Announces New Data Presentations from Pivotal Phase 3 REST-ON Trial of FT218 at Upcoming Conference
September 20 2021 - 8:00AM
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
transforming medicines to transform lives, today announced its
support of the third annual World Narcolepsy Day on Wednesday,
September 22. FT218 is the Company’s current lead drug candidate,
an investigational formulation of sodium oxybate designed to be
taken once at bedtime for the treatment of excessive daytime
sleepiness and cataplexy in adults with narcolepsy. FT218 is
currently under review at the U.S. Food and Drug Administration
with a Prescription Drug User Fee Act target date of October 15,
2021.
World Narcolepsy Day was established by 28 patient advocacy
organizations across six continents to raise global awareness and
improve outcomes for people with narcolepsy. As part of Avadel’s
support of World Narcolepsy Day, the Company recently launched
Narcolepsy Disrupts, a narcolepsy awareness campaign for patients,
their loved ones and healthcare providers about the importance of
prioritizing more natural sleep patterns. The campaign, which was
created based on insights from the patient community, provides
educational resources such as lifestyle changes and coping
strategies to help those with narcolepsy achieve better sleep.
“Excessive daytime sleepiness is my most bothersome symptom
during the day, but I also have hallucinations at night, which are
very frightening – so managing my condition 24/7 is challenging,”
said Diana, a person with narcolepsy type 2. “If I don’t nap on the
weekends, I cannot keep up with my husband and my 3-year-old son
and if I stay up late on weeknights, I can hardly keep up with my
job because of difficulty concentrating due to brain fog. I
appreciate the effort behind World Narcolepsy Day to help spread
awareness and educate people about what it’s like to live with
narcolepsy so that we can reduce delays in diagnosis."
Narcolepsy is a chronic neurological condition that impairs the
brain's ability to regulate the sleep-wake cycle and affects
approximately three million people globally. According to the
National Institute of Neurological Disorders and Stroke, symptoms
often start in childhood, adolescence or young adulthood (ages 7 to
25) but can occur at any time in life. Symptoms can vary by person
but may include excessive daytime sleepiness, disturbed nighttime
sleep, a sudden loss of muscle tone usually triggered by strong
emotion (cataplexy), sleep paralysis, and hypnagogic
hallucinations. Narcolepsy that occurs with cataplexy is called
type 1 narcolepsy. Narcolepsy that occurs without cataplexy is
known as type 2 narcolepsy.
“For people living with narcolepsy, the unpredictability of
their symptoms can leave them feeling ashamed, stigmatized socially
and scared to engage in activities they enjoy,” said Dr. Akinyemi
O. Ajayi, Sleep Specialist, Medical Director, Florida Pediatric
Research Institute. “Compounding the problem is that narcolepsy is
often undiagnosed or misdiagnosed, leaving those who suffer from it
without any options to manage their symptoms. World Narcolepsy Day
is a much needed awareness campaign to help educate the public of
the burdensome symptoms of narcolepsy and the need for improved
treatment options.”
“At Avadel, we have been longstanding supporters of the
narcolepsy community and are proud to reinforce our unwavering
commitment this World Narcolepsy Day by raising awareness and
elevating patient challenges,” said Greg Divis, Chief Executive
Officer of Avadel. “We understand that the relentless daytime and
nighttime symptoms of narcolepsy have a significant impact on
patients’ personal, professional and social lives. World Narcolepsy
Day is a much needed public awareness campaign, helping to reduce
stigma and increase visibility for those living with narcolepsy
around the world.”
In addition to supporting World Narcolepsy Day, Avadel is also
participating in upcoming patient and medical conferences,
including:
- The annual Narcolepsy Network conference, taking place
virtually October 2-3 where the Company is sponsoring a virtual
exhibit booth and presenting patient and clinician perspectives on
how to manage the disruption of narcolepsy.
- The American College of Chest Physicians annual meeting, taking
place virtually October 17 - 20 where new data will be shared in
three poster presentations.
- The annual meeting of the American Neurological Association),
taking place virtually October 17 - 19 where encore posters
featuring post hoc analyses from the REST-ON trial will be
presented.
About FT218FT218 is an investigational
formulation of sodium oxybate leveraging our proprietary drug
delivery technology and designed to be taken once at bedtime for
the treatment of excessive daytime sleepiness (EDS) and cataplexy
in adults with narcolepsy.
In March 2020, Avadel completed the REST-ON study, a randomized,
double-blind, placebo-controlled, pivotal Phase 3 trial, to assess
the efficacy and safety of FT218 in adults with narcolepsy. Among
the three co-primary endpoints, FT218 demonstrated statistically
significant and clinically meaningful results in EDS, the
clinician’s overall assessment of the patient’s functioning, and
reduction in cataplexy attacks, for all three evaluated does when
compared to placebo.
In January 2018, the U.S. Food and Drug Administration (FDA)
granted FT218 Orphan Drug Designation for the treatment of
narcolepsy based on the plausible hypothesis that FT218 may be
clinically superior to the twice-nightly formulation of sodium
oxybate already approved by the FDA for those with narcolepsy due
to the consequences of middle-of-the-night dosing of the approved
product. FT218 is currently under review by the FDA with a
Prescription Drug User Fee Act target date of October 15, 2021.
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. Our current lead drug candidate, FT218, is an
investigational formulation of sodium oxybate leveraging our
proprietary drug delivery technology and designed to be taken once
at bedtime for the treatment of excessive daytime sleepiness and
cataplexy in adults with narcolepsy. For more information, please
visit www.avadel.com.
Contacts:
Investor Contact:Courtney TurianoStern Investor
Relations, Inc. Courtney.Turiano@sternir.com (212) 698-8687
Media Contact:Nicole Raisch GoelzReal
Chemistryngoelz@realchemistry.com(408) 568-4292
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