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Axsome Reports Positive Results From Phase 3 Trial Of AXS-07 In Acute Treatment Of Migraine

Axsome Therapeutics Inc. (AXSM) announced positive efficacy and safety results from phase 3 movement long-term trial of AXS-07 in the acute treatment of migraine.

According to the company, treatment with AXS-07, rapidly, substantially, and durably relieved migraine pain and associated symptoms in this trial. AXS-07 was well tolerated over long-term treatment with a safety profile consistent with that observed in the previously reported controlled trials.

Two hours after administration of AXS-07, relief of migraine pain was achieved by 68% of patients and pain freedom by 38% of patients.

AXS-07 durably relieved migraine pain with 85% of patients free from rescue medication use through 24 hours, and 83% of patients free from rescue medication use through 48 hours after a single administration of AXS-07.

AXS-07 was well tolerated with long-term dosing. The safety profile of AXS-07 over the 12-month treatment period was consistent with that previously reported in short-term controlled trials.

Axsome said it remains on track to submit an new drug application or NDA for AXS-07 in the acute treatment of migraine in the first quarter of 2021.

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