Axsome Therapeutics Presents New Data from the EVOLVE Open-Label Trial Demonstrating Effects of ...
NEW YORK, Dec. 07, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that treatment with AUVELITY® (dextromethorphan HBr-bupropion HCl) resulted in rapid, substantial, and durable improvements in cognitive and physical functioning in the EVOLVE open-label trial in major depressive disorder (MDD). Treatment with AUVELITY also resulted in reduced disability. These new data were presented yesterday at the American College of Neuropsychopharmacology (ACNP) 2022 Annual Meeting being held in Phoenix, Arizona
Improvement in cognitive and physical functioning, measured by the CPFQ patient-rated scale, starting at week 1 and sustained over 12 months
Improvement in disability, measured by the SDS, starting at week 1 and sustained over 12 months
NEW YORK, Dec. 07, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that treatment with AUVELITY® (dextromethorphan HBr-bupropion HCl) resulted in rapid, substantial, and durable improvements in cognitive and physical functioning in the EVOLVE open-label trial in major depressive disorder (MDD). Treatment with AUVELITY also resulted in reduced disability. These new data were presented yesterday at the American College of Neuropsychopharmacology (ACNP) 2022 Annual Meeting being held in Phoenix, Arizona.
In the trial, 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. The change in cognitive and physical functioning was assessed using the Massachusetts General Hospital (MGH) Cognitive and Physical Functioning Questionnaire (CPFQ), a patient-rated scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The mean 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 (p<0.001 for all). Improvements on the CPFQ were sustained through month 6 (-9.5 points, p<0.001) and month 12 (-8.5 points, p<0.001). Disability was assessed using the Sheehan Disability Scale (SDS), a patient-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The mean 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 (p<0.001 for all). Improvements on the SDS were sustained through month 6 (-10.1 points, p<0.001) and month 12 (-10.8 points, p<0.001).
