By Colin Kellaher

 

Axsome Therapeutics Inc. on Tuesday said it plans to file for U.S. Food and Drug Administration approval of AXS-14 for the management of fibromyalgia by the end of next year.

The New York biopharmaceutical company said a pair of placebo-controlled trials have shown the potential for AXS-14 to improve the symptoms of the debilitating central-nervous-system condition, which currently has limited treatment options.

Axsome said it plans to submit a new drug application for AXS-14 in the fourth quarter of 2022, pending successful completion of manufacturing and other activities related to the product candidate.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

June 15, 2021 08:16 ET (12:16 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
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