GlobeNewswire Inc | Apr 8, 2021 08:00AM EDT

April 08, 2021

DUBLIN, Ireland, April 08, 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 that it is scheduled to present new secondary endpoint data from its pivotal REST-ON Phase 3 trial at the 2021 American Academy of Neurology (AAN) Annual Meeting, which is being held virtually from April 17-22, 2021.

Abstracts selected for presentation are summarized below.

Poster PresentationsTitle: Polysomnographic Measures of Sleep Continuity in Patients with Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate FormulationPresenter: Yves Dauvilliers, M.D., Ph.D., University of MontpellierAvailable: April 17, 2021

Title: Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients with Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate FormulationPresenter: Michael J. Thorpy, M.D., Albert Einstein College of MedicineAvailable: April 17, 2021

To register, visit AANs website: www.aan.com/conferences-community/annual-meeting.

AboutAvadel Pharmaceuticals plc:Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company primarily focused on the development and 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.

About FT218FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadels MicroPump controlled-release (CR) 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 New Drug Application (NDA) to the U.S. Food and Drug Administration (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 Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (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.

Contacts:

Investor ContactsTom McHughChief Financial OfficerPhone: (636) 449-1843Email: tmchugh@avadel.com Tim McCarthyLifeSci Advisors, LLCPhone: (212) 915.2564Email: tim@lifesciadvisors.com

Media ContactPatrick BurseyLifeSci Communications, LLCPhone: (646) 970-4688Email: pbursey@lifescicomms.com