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Axsome Therapeutics Announces Planned NDA Submission for AXS-14 for the Management of Fibromyalgia
Submission anticipated in 4Q 2022 NEW YORK, June 15, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":" Submission anticipated in 4Q 2022 NEW YORK, June 15, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced its plan to submit a New Drug Application (NDA) for AXS-14 for the management of fibromyalgia following a pre-NDA meeting with the U.S. Food and Drug Administration (FDA). AXS-14 (esreboxetine) is a novel, oral, potent, and highly selective norepinephrine reuptake inhibitor. The NDA submission is currently anticipated in the fourth quarter of 2022 pending successful completion of manufacturing and other activities related to the product candidate. Acceptance of the NDA will be subject to the FDA’s review of the complete filing. “Fibromyalgia is a debilitating central nervous system condition with limited treatment options. Results from two placebo-controlled trials demonstrate the potential for AXS-14 to significantly improve the symptoms of this serious condition,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We are excited by the potential of AXS-14 to expand the treatment options available to patients living with fibromyalgia, and look forward to completing manufacturing and other activities in anticipation of a planned NDA submission in the fourth quarter of next year.” AXS-14 has completed two positive placebo-controlled trials for the management of fibromyalgia, a Phase 3 and a Phase 2 trial, which will be included in the planned NDA submission: In the Phase 3 trial, 1,122 patients with fibromyalgia were treated with AXS-14 (esreboxetine) or placebo for 14 weeks. The study met the co-primary endpoints demonstrating statistically significant improvements compared to placebo in the weekly mean pain score (p","length":2256,"tagName":"div"}]