Axsome Therapeutics Licenses Pfizer’s Potential Fibromyalgia Treatment Esreboxetine in US

Axsome Therapeutics Licenses Pfizer’s Potential Fibromyalgia Treatment Esreboxetine in US
Following an agreement with Pfizer, Axsome Therapeutics now has exclusive rights to develop and commercialize AXS-14 (esreboxetine) — a drug candidate for treatment of fibromyalgia — in the United States. Axsome also has obtained an exclusive U.S. license for Pfizer’s AXS-12 (reboxetine), in development for the treatment of narcolepsy. “We are very pleased to announce this agreement with Pfizer to help advance the development of AXS-12 for the treatment of narcolepsy and of AXS-14 for the treatment of fibromyalgia, two serious CNS [central nervous system] disorders which currently have limited treatment options,” Herriot Tabuteau, MD, CEO of Axsome, said in a press release. According to the agreement, Axsome will be given an exclusive U.S. license to Pfizer’s data for AXS-12 and AXS-14, which encompasses a wide range of nonclinical studies, and both short-term and long-term clinical trials that involve more than 5,000 patients. The data also includes results from a Phase 2 and Phase 3 clinical trial of AXS-14 for the treatment of fibromyalgia. A highly selective norepinephrine reuptake inhibitor, AXS-14 has been shown to block the sensation of pain in preclinical models. Results from the Phase 3 clinical trial (NCT00612170), conducted in 1,122 patients with fibromyalgia, showed significant improvements compared with placebo in the weekly mean pain score, Fibromyalgia Impact Questionnaire (FIQ) total score, Patient’s Global Impression of Change (PGIC) scale, and fatigue. Further, results from the Phase 2 trial (NCT00357825) showed significant improvements compared with placebo in the weekly mean pain score, the FIQ total score, the PGIC scale, and fatigue. “The valuable clinical and nonclinical data under this exclusive license will e
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