AXSM - Axsome's depression drug Auvelity sustains improvements in symptoms in trial

Axsome Therapeutics ( NASDAQ: AXSM ) said it medicine Auvelity showed substantial and durable improvements in cognitive and physical functioning in patients with major depressive disorder (MDD) in the open-label trial EVOLVE.

Auvelity is approved to treat MDD in adults.

In the trial, 146 patients with MDD who had received one or more prior antidepressants were treated with Auvelity (dextromethorphan HBr-bupropion HCl) twice daily for up to 15 months.

The main goal was the change from baseline to week 6 on the Montgomery-?sberg Depression Rating Scale (MADRS) total score.

In the study, Auvelity  rapidly, durably, and substantially improved symptoms of depression including cognitive and physical functioning, and reduced disability in patients with MDD who had received one or more prior antidepressants, according to the company.

The change in cognitive and physical functioning was evaluated using the Massachusetts General Hospital (MGH) Cognitive and Physical Functioning Questionnaire (CPFQ), a patient-rated scale to measure cognitive and executive dysfunction.

The company said average CPFQ score at baseline was 28.4. Mean improvements from baseline to weeks 1, 2, and 6 in CPFQ scores were -2.0 points, -4.4 points, and -7.5 points, respectively.

Improvements on the CPFQ were sustained through month 6 (-9.5 points) and month 12 (-8.5 points).

Meanwhile, disability was tested using the Sheehan Disability Scale ( SDS ), a patient-facing questionnaire.

The average SDS score at baseline was 17.5. Mean improvements from baseline to weeks 1, 2, and 6 in SDS scores were -2.9 points, -5.0 points, and -8.3 points, respectively.

Axsome said improvements on the SDS were sustained through month 6 (-10.1 points) and month 12 (-10.8 points).

The company added that Axsome was generally well tolerated with long-term treatment and a safety profile consistent with that seen in previously reported trials.

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