Avadel Pharmaceuticals Completes the REST-ON Phase 3 Pivotal Trial of FT218 for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy
March 25, 2020 at 08:00 AM EDT
DUBLIN, Ireland, March 25, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has completed the REST-ON Phase 3 clinical trial for FT218. The REST-ON study enrolled a total of 212 patients, and the last patient last visit occurred earlier this week. The Company currently expects to announce topline data from the study in the second quarter of 2020.
“We’re excited to complete our pivotal Phase 3 REST-ON study of FT218 and look forward to announcing the topline data from the study as we move closer toward potentially bringing this new drug to narcolepsy patients. I want to thank our investigators, study staff and patients for their participation in this study, as well as the Avadel team for their continued dedication,” stated Dr. Jordan Dubow, Chief Medical Officer of Avadel.
The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of FT218, a once-nightly formulation of sodium oxybate using Avadel’s proprietary Micropump™ technology for extended-release oral suspension, for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The REST-ON study is under a Special Protocol Assessment agreement with FDA.
Based on the Company’s industry research, it believes FT218, if approved by the FDA, has the potential to provide a valuable advancement in the treatment of both excessive daytime sleepiness and cataplexy for patients with narcolepsy. Currently, the twice-nightly sodium oxybate market is valued at an estimated annualized rate of $1.7 billion1.
About Avadel Pharmaceuticals plc:
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. Actual results (including, without limitation, the timely announcement of topline data and success of our Phase 3 REST-ON study and our ability to achieve FDA approval for FT218) may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involved certain risks and uncertainties that are subject to change based on various factors (many of which are beyond our control) including those set forth in our 2019 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and subsequent 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 the forward-looking statements contained in this Annual Report.