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Avadel Pharmaceuticals Completes Enrollment in the REST-ON Phase 3 Pivotal Trial of FT218 for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy
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A total of 212 patients enrolled in the REST-ON study exceeds the trial’s enrollment target of 205
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Topline data from the REST-ON study expected in Q2 2020
“We’re excited to complete enrollment in our pivotal Phase 3 REST-ON study and move towards completing the study in the next three months. As a result, the study is on schedule to allow us to announce topline data in the second quarter of 2020,” stated Dr.
Based on the Company’s industry research, it believes FT218, if approved by the
About FT218
FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a 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. FT218 has been granted Orphan Drug Designation from the
About Avadel Pharmaceuticals plc:
Footnote:
1. Annualized Xyrem revenues from
Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project” and similar expressions, and the negatives thereof (if applicable).
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 of our research, development and commercialization activities 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 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
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.
Contacts: |
|
Tom McHugh | |
Chief Financial Officer | |
Phone: (636) 449-1843 | |
Email: tmchugh@avadel.com | |
Tim McCarthy | |
LifeSci Advisors, LLC | |
Phone: (212) 915.2564 |
|
Email: tim@lifesciadvisors.com |
Source: Avadel Pharmaceuticals plc