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After a pre-NDA meeting with FDA, Axsome Therapeutics Inc (NASDAQ: AXSM) has announced its plan to submit a marketing application seeking approval for AXS-14 to manage fibromyalgia.
The submission is currently anticipated in the fourth quarter of 2022, pending completion of manufacturing and other activities related to the product candidate.
AXS-14 has completed two positive placebo-controlled trials, a Phase 3 and a Phase 2 trial, which will be included in the submission.
Fibromyalgia is a chronic debilitating disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment.
Approximately 5 million Americans are estimated to suffer from fibromyalgia, with treatment options limited with only three pharmacologic treatments currently approved by the FDA.
Price Action: AXSM shares are up 2.6% at $69.28 during the market session on the last check Tuesday.
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