Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
transforming medicines to transform lives, announced today it will
present eight posters at World Sleep 2022, taking place March 11-16
in Rome, Italy. The presentations will feature new data from the
completed pivotal Phase 3 REST-ON clinical trial of FT218 and the
ongoing RESTORE open-label extension/switch study of FT218. Results
from discrete choice experiments designed to understand patient and
healthcare provider preferences associated with oxybate treatments
for narcolepsy and perspectives on narcolepsy disease burden,
treatment approaches and satisfaction with current narcolepsy
treatment options will also be presented. FT218, also known as
ON-SXB, is the Company’s lead drug candidate, an investigational
formulation of sodium oxybate designed to be taken once at bedtime
for the treatment of excessive daytime sleepiness (EDS) or
cataplexy in adults with narcolepsy. FT218 is currently under
review at the U.S. Food and Drug Administration.
Details of Avadel’s poster presentations are below:
Title: Patient and Healthcare Provider Surveys
of Narcolepsy Disease Burden and Oxybate Treatment
ExperiencePresenter: Anne Marie Morse, D.O.,
director of child neurology and pediatric sleep medicine at
Geisinger Medical Center at Janet Weis Children’s
HospitalDate and Time: Tuesday, March 15 at 5:30
p.m. CET (Poster Group A)
Title: Patient and Provider Preferences for
Oxybate Treatment for Narcolepsy: A Discrete Choice
ExperimentPresenter: Anne Marie Morse, D.O.,
director of child neurology and pediatric sleep medicine at
Geisinger Medical Center at Janet Weis Children’s
HospitalDate and Time: Tuesday, March 15 at 5:30
p.m. CET (Poster Group A)
Title: Long-Term Safety of Once-Nightly Sodium
Oxybate: Interim Data From
RESTOREPresenter: David Seiden, MD, FAASM,
Senior Medical Director, Clinical Development & Medical Affairs
· Avadel PharmaceuticalsDate and Time: Tuesday,
March 15 at 5:30 p.m. CET (Poster Group A)
Title: Efficacy of Once-Nightly Sodium Oxybate
(ON-SXB; FT218) By Narcolepsy Type: Post-hoc Analyses From the
REST-ON TrialPresenter: Yves Dauvilliers, M.D.,
Ph.D., director of the Sleep and Wake Disorders Centre in the
Department of Neurology at the Gui de Chauliac Hospital in
Montpellier, FranceDate and Time: Monday, March 14
at 6:15 p.m. CET (Poster Group B)
Title: Early Efficacy With Once-Nightly Sodium
Oxybate (ON-SXB; FT218): Post-hoc Analyses From
REST-ONPresenter: Lois Krahn, MD, Mayo Clinic
Center for Sleep MedicineDate and Time: Monday,
March 14 at 5:30 p.m. CET (Poster Group A)
Title: Efficacy of Once-Nightly Sodium Oxybate
(ON-SXB; FT218) Across Stimulant Use Subgroups: Post-hoc Analyses
From the REST-ON TrialPresenter: Michael J.
Thorpy, M.D., director of the Sleep-Wake Disorders Center at
Montefiore and professor of neurology at Albert Einstein College of
MedicineDate and Time: Tuesday, March 15 at 5:30
p.m. CET (Poster Group A)
Title: Efficacy of FT218, a Once-Nightly Sodium
Oxybate Formulation, in Patients With Narcolepsy: Post-hoc
Sensitivity Analyses From the REST-ON
TrialPresenter: Clete Kushida, M.D., Ph.D.,
division chief and medical director of Stanford Sleep Medicine,
neurologist and professor in the department of psychiatry and
behavioral sciences at Stanford University Medical Center and
director of the Stanford Center for Human Sleep Research at
Stanford UniversityDate and Time: Monday, March 14
at 5:30 p.m. CET (Poster Group A)
Title: Efficacy of Once-nightly Sodium Oxybate
(ON-SXB; FT218) for Excessive Daytime Sleepiness and Cataplexy:
Post-hoc Number Needed to Treat and Effect Size Analyses From
REST-ONPresenter: Michael J. Thorpy, M.D.,
director of the Sleep-Wake Disorders Center at Montefiore and
professor of neurology at Albert Einstein College of Medicine
Date and Time: Monday, March 14 at 6:15 p.m. CET
(Poster Group B)
In addition to Avadel’s poster presentations, the Company will
support a Satellite Symposium titled “Avadel Pharmaceuticals:
Addressing patient needs in the advancement of narcolepsy
treatment” on Tuesday, March 15 from 12:30 – 2:00 p.m. CET. The
symposium will feature panel presentations from Yves Dauvilliers,
M.D., Ph.D., director of the Sleep and Wake Disorders Centre in the
Department of Neurology at the Gui de Chauliac Hospital in
Montpellier, France; Michael J. Thorpy, M.D., director of the
Sleep-Wake Disorders Center at Montefiore and professor of
neurology at Albert Einstein College of Medicine; Clete Kushida,
M.D., Ph.D., division chief and medical director of Stanford Sleep
Medicine, neurologist and professor in the department of psychiatry
and behavioral sciences at Stanford University Medical Center and
director of the Stanford Center for Human Sleep Research at
Stanford University; and Anne Marie Morse, D.O., director of child
neurology and pediatric sleep medicine at Geisinger Medical Center
at Janet Weis Children’s Hospital.
About NarcolepsyNarcolepsy is a chronic
neurological condition that impairs the brain's ability to regulate
the sleep-wake cycle. The condition affects approximately one in
2,000 people in the United States with the cardinal symptom of
excessive daytime sleepiness. Additional symptoms can vary by
person and may include disrupted nighttime sleep, a sudden loss of
muscle tone usually triggered by strong emotion (cataplexy), sleep
paralysis and hypnagogic hallucinations.
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) or 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.
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.
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
Avadel Pharmaceuticals (NASDAQ:AVDL)
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