Avadel to Present New Efficacy and Safety Data from Pivotal Phase 3 REST-ON Trial of FT218 at SLEEP 2021
03 6월 2021 - 9:00PM
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
developing FT218, an investigational, once-nightly formulation of
sodium oxybate for treating excessive daytime sleepiness and
cataplexy in adults with narcolepsy, today announced it will
present primary and secondary endpoint data, including new post hoc
analyses, from the pivotal Phase 3 REST-ON clinical trial at SLEEP
2021, at the 35th Annual Meeting of the Associated Professional
Sleep Societies (APSS). This joint meeting of the American Academy
of Sleep Medicine and the Sleep Research Society is being held
virtually from June 10-13, 2021.
Avadel will present FT218 efficacy and safety data from six
abstracts, which have been published in an online supplement in the
journal Sleep. Details of the presentations are as follows:
Oral Presentation
Abstract #:
488Title: REST-ON: Efficacy of FT218 for
Daytime Sleepiness, Sleep Quality, Hallucinations and Sleep
Paralysis in Patients with
NarcolepsyPresenter: Michael J. Thorpy,
M.D., Albert Einstein College of
MedicineSession: O-14: Innovation in the
Assessment and Management of Central HypersomniaDate and
Time: Sunday, June 13, 2021 at 1:03-1:14 p.m. EDT
The oral presentation will also be available as a poster.
Poster Presentations
Abstract #:
491Title: Efficacy of FT218, a Once-Nightly
Sodium Oxybate Formulation, by Narcolepsy Subtype: A Post Hoc
Analysis from the REST-ON StudyPresenter: Asim
Roy, M.D., Ohio Sleep Medicine InstituteAbstract
#: 492Title: Efficacy of FT218, a
Once-Nightly Sodium Oxybate Formulation, by Stimulant Use: A Post
Hoc Analysis from the REST-ON
StudyPresenter: Asim Roy, M.D., Ohio
Sleep Medicine Institute
Abstract #:
493Title: Weight Loss with FT218, a
Once-Nightly Sodium Oxybate Formulation for the Treatment of
Narcolepsy: Post Hoc Analysis from
REST-ONPresenter: Anne Marie Morse, D.O.,
Geisinger Medical Center, Janet Weis Children’s Hospital
Abstract #:
489Title: Pivotal Phase 3 Study of FT218, a
Once-Nightly Sodium Oxybate Formulation, in Patients with
Narcolepsy: REST-ON Primary
ResultsPresenter: Clete Kushida
M.D., Ph.D., Stanford Sleep Medicine Center
Abstract #:
490Title: Efficacy of FT218 on
Polysomnographic Measures of Sleep Continuity in Patients with
Narcolepsy: Results from the REST-ON
TrialPresenter: Yves Dauvilliers,
M.D., Ph.D., Sleep and Wake Disorders Centre, Department of
Neurology, Gui de Chauliac Hospital
For registered meeting attendees, posters will be available from
June 11 to November 30, 2021, in the e-Poster gallery on the SLEEP
2021 website at https://www.sleepmeeting.org/. Posters also will be
housed in Avadel’s virtual medical booth, with the three posters
covering pre-specified primary and secondary endpoints featured in
an interactive format with commentary from Dr. Roy, medical
director of the Ohio Sleep Medicine Institute. The booth will also
include more detailed information about the Company and its ongoing
research and publications.
In addition to Avadel’s virtual medical booth, the Company will
support a symposium titled “How Narcolepsy Management Is Evolving:
Expert Panel Discussion.” The symposium will be moderated by Dr.
Thorpy, director of the Sleep-Wake Disorders Center at Montefiore
and professor of neurology at Albert Einstein College of Medicine,
and will be available on-demand on the SLEEP 2021 website and in
the Company’s virtual medical booth until November 30, 2021.
About FT218FT218 is an investigational,
once-nightly formulation of sodium oxybate that includes Avadel’s
MicroPump™ controlled-release technology. In March of 2020, the
Company completed the REST-ON study, a pivotal, double-blind,
randomized, placebo-controlled Phase 3 trial, to assess the
efficacy and safety of FT218 in the treatment of excessive daytime
sleepiness and cataplexy in patients suffering from narcolepsy. In
December 2020, the Company submitted a NDA to the FDA for FT218 to
treat excessive daytime sleepiness and cataplexy in adults with
narcolepsy. The NDA for FT218 was accepted by the FDA in February
2021 and assigned a PDUFA target action date of October 15, 2021.
FT218 has been granted Orphan Drug Designation from the FDA for the
treatment of narcolepsy. The designation was granted on the
plausible hypothesis that FT218 may be clinically superior to the
twice-nightly formulation of sodium oxybate already approved by the
FDA for the same indication. In particular, FT218 may be safer due
to ramifications associated with the dosing regimen of the
previously approved product.
About Avadel Pharmaceuticals plcAvadel
Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical
company primarily focused on the development and U.S. Food and Drug
Administration (FDA) approval of FT218, an investigational,
once-nightly, extended-release formulation of sodium oxybate
designed to treat 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
Avadel Pharmaceuticals (NASDAQ:AVDL)
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Avadel Pharmaceuticals (NASDAQ:AVDL)
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