AVADEL PHARMACEUTICALS PLC (NASDAQ:AVDL) Files An 8-K Other EventsItem 8.01 Other Events
On January 10, 2018, the Company issued a press release announcing that the U.S. Food & Drug Administration granted Orphan Drug Designation to FT 218 for the treatment of narcolepsy. FT 218 is the Company's once-nightly formulation of sodium oxybate using its Micropump® technology that is currently undergoing testing in a Phase III clinical trial for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. A copy of this press release is attached hereto as Exhibit 99.1.
The information responsive to this Item 8.01 of this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of 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 or the Exchange Act, except as may be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
* This information shall be deemed to be "furnished" and not filed herewith.
AVADEL PHARMACEUTICALS PLC ExhibitEX-99.1 2 avadelrecievesodd_v2clean.htm EXHIBIT 99.1 Exhibit Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for FT 218 for the Treatment of NarcolepsyDublin,…To view the full exhibit click