Axsome Therapeutics Announces Planned NDA Submission for AXS-14 for the Management of Fibromyalgia
Submission anticipated in 4Q 2022
“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
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).
Fibromyalgia is a chronic debilitating disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment. Other symptoms of this disorder can include tingling in the hands and feet and headaches. Fibromyalgia has considerable detrimental effects on physical, emotional, social, and day-to-day functioning. Fibromyalgia is considered to be mediated mainly in the central nervous system. Approximately 5 million Americans, 90% of whom are women, are estimated to suffer from fibromyalgia. Treatment options for fibromyalgia are limited with only three pharmacologic treatments currently approved by the FDA.
AXS-14 (esreboxetine) is a highly selective and potent norepinephrine reuptake inhibitor for the management of fibromyalgia and other conditions. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. AXS-14 is an investigational drug product not approved by the FDA.
Forward Looking Statements
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Source: Axsome Therapeutics, Inc.