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Axsome starts AXS-05 smoking cessation trial
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Axsome starts AXS-05 smoking cessation trial

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  • Axsome Therapeutics dosed the first patient in its Phase 3 SUMMIT trial evaluating AXS-05 for smoking cessation.
  • The trial will compare AXS-05 with bupropion and placebo in adult smokers over approximately 12 weeks.
  • The primary endpoint is smoking abstinence at week 12.

Axsome Therapeutics (NASDAQ:AXSM) announced that the first patient has been dosed in SUMMIT, a Phase 3 trial evaluating AXS-05 for smoking cessation in adult smokers.

The randomized, double-blind, active- and placebo-controlled study will compare AXS-05 with bupropion and placebo as Axsome advances clinical development of the treatment.

The SUMMIT trial will evaluate patients over approximately 12 weeks across multiple clinical sites, with smoking abstinence at week 12 serving as the primary endpoint.

Axsome Therapeutics said the trial has started patient dosing as planned.

Axsome Therapeutics develops therapies for central nervous system disorders and is advancing multiple clinical programs targeting neurological and psychiatric conditions.

The company is evaluating AXS-05 as a potential treatment option for smoking cessation, with the Phase 3 SUMMIT study designed to compare its effects against an established smoking cessation medicine and placebo.

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