01-04-2025
Axsome to narrow focus of depression drug trial after limited success in initial run
April 1 (Reuters) - Axsome Therapeutics (AXSM.O), opens new tab said on Tuesday it will narrow the focus of a late-stage study of its depression drug after an initial run of the trial showed improvement only in a small subgroup of patients.
The drug, solriamfetol, did not show statistically significant improvement in the overall group of patients.
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However, it helped reduce symptoms in some patients with major depressive disorder who also suffered from excessive daytime sleepiness (EDS), a common symptom of MDD.
"The study missing in the overall MDD population limits the market opportunity significantly, and is disappointing given the company's expertise in the space," RBC Capital Markets analyst Leonid Timashev said in a client note.
Axsome said it plans to start a larger late-stage study of the drug in MDD patients with EDS this year.
The initial late-stage study that served as a proof of concept for the larger trial had enrolled 346 participants with MDD, of which 51 patients had severe EDS, the company said.
The drug was well-tolerated in the study with no new safety concerns, Axsome said.
Each year, around 21 million adults in the U.S. are affected by MDD, according to the company.
Solriamfetol has already been approved in the U.S. to improve wakefulness in adults with excessive sleepiness from sleep disorders, narcolepsy and sleep apnea, and is sold under the brand Sunosi.
