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Avadel Presents New Data from its Pivotal REST-ON Phase 3 Trial of FT218, once-nightly sodium oxybate, at the 2021 American Academy of Neurology Annual Meeting
DUBLIN, Ireland, April 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate (ON-SXB) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021. “The positive results previously disclosed from the REST-ON trial, regarding the three co-primary endpoints, are further bolstered by the secondary endpoints presented at AAN. The consistency with which FT218, or once-nightly sodium oxybate, improved both subjective and objective symptoms of narcolepsy – including disturbed nocturnal sleep – represent the promise of a potential new treatment strategy for physicians and patients. I am particularly impressed by the consistency of results as early as three weeks, with only a 6 g dose,” said Michael J. Thorpy, M.D., Investigator on the REST-ON Phase 3 trial and Director at the Sleep-Wake Disorders Center at Montefiore Medical Center and Professor of Neurology at the Albert Einstein College of Medicine. “I know that clinicians have been eager to learn more about a once-nightly form of sodium oxybate, and we appreciate this forum to present these data.” Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs at Avadel, added, “FT218 demonstrated significant (P<0.001) and clinically meaningful results versus placebo at all doses tested for secondary endpoints of the Epworth Sleepiness Scale, sleep quality and refreshing nature of sleep, sleep paralysis, and disturbed nocturnal sleep, representing an improvement on important narcolepsy symptoms. We are pleased that neurologists attending AAN will have the opportunity to learn about a once-nightly form of sodium oxybate. We believe that patient perspective is critical to successful long-term therapy, and we are presenting several positive endpoints supporting symptomatic improvement as determined directly by patients.” To register for the meeting, visit AAN’s website: www.aan.com/conferences-community/annual-meeting. Data highlights from the poster presentations are outlined below: 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 Formulation
About Avadel Pharmaceuticals plc About FT218 Cautionary Disclosure Regarding Forward-Looking Statements Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include: the risk that positive results from the REST-ON trial may not necessarily be predictive of the results of future or ongoing clinical studies; the risk that the NDA for FT218 is not approved by the FDA or such approval is delayed; the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity; the risk that commercial launch of FT218 (if approved) is delayed or never occurs; the risk that the potential market performance for FT218 (if approved) may differ materially from projections; and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020, which we filed with the Securities and Exchange Commission (SEC) on March 9, 2021 and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Contacts: Investor Contacts Media Contact |