8-K 1 orphandrug8k.htm 8-K Document




UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________

FORM 8-K
___________________

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 11, 2018
___________________

AVADEL PHARMACEUTICALS PLC
(Exact name of registrant as specified in its charter)
___________________
Ireland
(State or Other Jurisdiction
of Incorporation)
 
001-37977
(Commission File Number)
98-1341933
(I.R.S. Employer
Identification No.)
 
Block 10-1
Blanchardstown Corporate Park, Ballycoolin
Dublin 15, Ireland
 (Address of Principal Executive Offices)
 
 
 
Not Applicable
(Zip Code)
 
 

Registrant's telephone number, including area code: +353 1 485 1200
___________________


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o












Item 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.
 
(d) Exhibits
 
* This information shall be deemed to be "furnished" and not filed herewith.

 


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
          AVADEL PHARMACEUTICALS PLC
          By:            /s/ Phillandas T. Thompson
           Phillandas T. Thompson
           Senior Vice President, General Counsel and Corporate Secretary
Date: January 11, 2018

 Exhibit Index
99.1
 
Press release dated January 10, 2018, issued by Avadel Pharmaceuticals plc*