Benzinga | Jun 15, 2021 07:01AM EDT

Axsome Therapeutics Announces Planned NDA Submission For AXS-14 For Management Of Fibromyalgia; Submission Anticipated In Q4

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<0.001, p<0.001, and p=0.025, for the 4 mg, 8 mg and 10 mg daily doses, respectively), and the Fibromyalgia Impact Questionnaire (FIQ) total score (p<0.001, p<0.001, and p=0.023, for the 4 mg, 8 mg and 10 mg doses, respectively). AXS-14 also resulted in statistically significant improvements as compared to placebo on the Patient's Global Impression of Change (PGI-C) scale (p=0.002, p=0.001, and p=0.007, for the 4 mg, 8 mg and 10 mg doses, respectively), and in fatigue as measured using the Global Fatigue Index (p=0.001 and p=0.001, for the 4 mg and 8 mg daily doses, respectively).

* In the Phase 2 trial, 267 patients with fibromyalgia were treated with AXS-14 (esreboxetine) (dose escalated to 8 mg/day) or placebo for 8 weeks. The study met its primary endpoint demonstrating statistically significant improvements compared to placebo in the weekly mean pain score (p=0.006). The study also demonstrated statistically significant improvements in additional efficacy outcomes including the FIQ total score (p<0.001), the PGIC scale (p<0.001), and fatigue as measured using the Multidimensional Assessment of Fatigue scale (p<0.001).