AVADEL PHARMACEUTICALS PLC (NASDAQ:AVDL) Files An 8-K Regulation FD Disclosure
Item 7.01.
On April 27, 2020, Avadel Pharmaceuticals plc (the “Company”) issued a press release to announce topline results from its Phase 3 REST-ON clinical trial for FT218. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The Company also updated its corporate presentation for use in meetings with investors, analysts and others. A copy of the updated corporate presentation is furnished herewith as Exhibit 99.2 and incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials furnished herewith as Exhibit 99.2.
The information furnished under this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
FT218 Phase 3 Clinical Trial Topline Results
On April 27, 2020, the Company announced topline results from its Phase 3 REST-ON clinical trial of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. The REST-ON trial is a randomized, double-blind, placebo-controlled study that enrolled 212 patients and was conducted in clinical sites in the United States, Canada, Western Europe and Australia. Patients who received 9g of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement compared to placebo across the three co-primary endpoints of the trial: maintenance of wakefulness test, or MWT, clinical global impression-improvement, or CGI-I, and mean weekly cataplexy attacks. P-value was <0.001 for all three co-primary endpoints.
| (d) | Exhibits |
| 99.1 | Press release issued by the Company on April 27, 2020, furnished herewith. |
| 99.2 | Corporate presentation of Avadel Pharmaceuticals plc, dated April 27, 2020, furnished herewith. |
AVADEL PHARMACEUTICALS PLC Exhibit
EX-99.1 2 tm2017769d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial of Once-Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy – – – The primary analysis of investigational,…
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