Axsome Therapeutics, Inc.AXSM

Axsome Therapeutics, Inc. (AXSM) focuses on psychiatry. The company's regulatory documents detail studies for drugs like Solriamfetol and AXS-05 (Auvelity).

For Solriamfetol, studies reported irritability and agitation in the all Solriamfetol group at 3.6% in Study 14-005 (OSA), 2.7% in Study 14-005 (Narcolepsy), and 3.1% in Study 14-003. In Study ADX-N05-202, TEAEs for irritability and agitation were 9.1% in the solriamfetol combined group, compared to 2.0% in the placebo group. For Auvelity, the MDD-301 trial, a Phase 3 study conducted across 43 sites in the United States, aimed for 90% power with 300 subjects, 150 subjects per arm, and a randomization ratio of 1:1. The primary efficacy endpoint was the change from baseline to Week 6 in MADRS total score. Subjects in MDD-301 were aged 18 to 65 years, with a QIDS-SR-16 score for diagnosis confirmation of ≥13, a MADRS total score for moderate or greater severity of ≥25, and a CGI-S score for moderate or greater severity of ≥4. Remission was defined as a MADRS total score of ≤10, and responders showed a MADRS total score reduction of ≥50%.

Safety database recommendations for AXS-05, according to ICH E1 Guideline, include 1500 subjects for short-term exposure, 300 to 600 subjects for at least 6 months exposure, and 100 subjects for at least 1 year exposure. The MDD-201 trial, a Phase 2 study in the United States, randomized 120 subjects with 60 subjects per arm and a randomization ratio of 1:1. The primary efficacy endpoint was the mean change from baseline to Week 6 in MADRS total score. Subjects in MDD-201 had a BMI range of 18 and 40 kg/m2, a QIDS-SR-16 score for diagnosis confirmation of ≥13, a MADRS total score for moderate or greater severity of ≥25, and a CGI-S score for moderate or greater severity of ≥4. 80 subjects were in the mITT population and 60 subjects completed the study.