Axsome’s Depression Drug Meets Phase 3 Goals, FDA Filing Planned

Xconomy New York — 

An experimental Axsome Therapeutics drug has succeeded in improving depression symptoms in a late-stage study, and the company is now preparing to seek regulatory approval next year.

Axsome (NASDAQ: AXSM) is testing its drug, AXS-05, as a treatment for major depressive disorder (MDD). The Phase 3 study enrolled 327 patients with moderate-to-severe major depressive disorder. Those patients were randomly assigned to receive either the Axsome drug or a placebo once daily for the first three days, and twice a day afterward, for six weeks. Patients were evaluated according to a rating scale used to assess the severity of depressive episodes.

In the group that received the Axsome pill, the average reduction in symptoms on the depression scale was 16.6 points compared to 11.9 points in the placebo group, which the company says is enough to be statistically significant. Axsome says the results also showed its drug worked quickly, with improvements in symptoms observed in the first week of the study. Those effects continued for the rest of the clinical trial.

Following the announcement of the Phase 3 results on Monday, Axsome’s stock price shot up more than 77 percent to $83.10 per share in pre-market trading.

Axsome’s drug is intended to block NMDA receptors, which play a role in psychiatric disorders. The company says this approach is thought to help enhance synaptic connections and improve the communication between the brain cells of people who have major depressive disorder. AXS-05 combines dextromethorphan with buproprion, and uses the company’s metabolic inhibition technology. Axsome says this technology increases how much of the drug is absorbed by the body, and how long its effect lasts.

The most common side effects reported in the Phase 3 study were dizziness, nausea, headache, diarrhea, drowsiness, and dry mouth. The company reported no psychotic effects or weight gain, problems associated with some depression drugs.

Based on the preliminary results of the Phase 3 study, Axsome plans a regulatory submission with the FDA in the second half of next year. Detailed results from the study, including secondary endpoints, will be submitted for presentation at upcoming medical meetings and for publication. The company is also evaluating the drug in a separate Phase 3 study testing it in treatment resistant depression, which is defined as patients with MDD who have failed to respond to two or more antidepressant treatments. Another study is evaluating the drug as a treatment for agitation in Alzheimer’s disease patients.

Photo by Flickr user Jens Karlsson via a Creative Commons license