Avadel to Present New Efficacy and Safety Data from Pivotal Phase 3 REST-ON Trial of FT218 at SLEEP 2021

Rhea-AI Summary

Avadel Pharmaceuticals (Nasdaq: AVDL) announced it will present pivotal Phase 3 REST-ON clinical trial data for FT218 at the virtual SLEEP 2021 meeting from June 10-13, 2021. FT218, a once-nightly formulation of sodium oxybate, targets excessive daytime sleepiness and cataplexy in narcolepsy patients. The presentation includes six abstracts focusing on various efficacy and safety aspects. The FDA has accepted the NDA for FT218, aiming for a decision by October 15, 2021, and granted it Orphan Drug Designation, indicating potential clinical superiority over existing treatments.

Positive

• Presentation of pivotal Phase 3 REST-ON trial data at SLEEP 2021, highlighting efficacy and safety of FT218.
• NDA for FT218 accepted by the FDA with a PDUFA action date of October 15, 2021.
• FT218 has received Orphan Drug Designation from the FDA, suggesting potential clinical superiority over existing treatments.

Negative

• None.

DUBLIN, Ireland, June 03, 2021 (GLOBE NEWSWIRE) -- 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 35^th 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 #: 488
Title: REST-ON: Efficacy of FT218 for Daytime Sleepiness, Sleep Quality, Hallucinations and Sleep Paralysis in Patients with Narcolepsy
Presenter: Michael J. Thorpy, M.D., Albert Einstein College of Medicine
Session: O-14: Innovation in the Assessment and Management of Central Hypersomnia
Date 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 #: 491
Title: Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Narcolepsy Subtype: A Post Hoc Analysis from the REST-ON Study
Presenter: Asim Roy, M.D., Ohio Sleep Medicine Institute

Abstract #: 492
Title: Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Stimulant Use: A Post Hoc Analysis from the REST-ON Study
Presenter: Asim Roy, M.D., Ohio Sleep Medicine Institute

Abstract #: 493
Title: Weight Loss with FT218, a Once-Nightly Sodium Oxybate Formulation for the Treatment of Narcolepsy: Post Hoc Analysis from REST-ON
Presenter: Anne Marie Morse, D.O., Geisinger Medical Center, Janet Weis Children’s Hospital

Abstract #: 489
Title: Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation, in Patients with Narcolepsy: REST-ON Primary Results
Presenter: Clete Kushida M.D., Ph.D., Stanford Sleep Medicine Center

Abstract #: 490
Title: Efficacy of FT218 on Polysomnographic Measures of Sleep Continuity in Patients with Narcolepsy: Results from the REST-ON Trial
Presenter: 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 FT218
FT218 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 plc
Avadel 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 Turiano
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
(212) 698-8687

Media Contact:
Nicole Raisch Goelz
Real Chemistry
ngoelz@realchemistry.com
(408) 568-4292

FAQ

What is the purpose of the Phase 3 REST-ON trial for AVDL?

The Phase 3 REST-ON trial evaluates the efficacy and safety of FT218, a once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy.

When will AVDL present data from the REST-ON trial?

AVDL will present the data from the REST-ON trial at the SLEEP 2021 meeting from June 10-13, 2021.

What is the significance of the Orphan Drug Designation for FT218?

The Orphan Drug Designation indicates that FT218 may be clinically superior to existing treatments, potentially leading to better safety and efficacy for patients with narcolepsy.

What are the key dates related to the FDA review of FT218?

The FDA accepted the NDA for FT218 in February 2021, with a target action date set for October 15, 2021.