Axsome Therapeutics to Seek FDA OK of AXS-14 for Fibromyalgia by End 2022
June 15 2021 - 08:30AM
Dow Jones News
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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