April 1 (Reuters) - Axsome Therapeutics ( AXSM ) 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.
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.