The trial results take the company a step closer to acquiring a share of the multi-billion dollar market for depression drugs.
Major depressive disorder is a chronic condition that makes patients feel low, experience guilt and worthlessness. In extreme cases, it may lead to suicide.
Axsome said its oral tablet, AXS-05, improves the communication between brain cells and increases levels of serotonin, noradrenaline and dopamine, all of which help regulate mood.
The company said patients on AXS-05, which has been granted a breakthrough therapy designation by the FDA, showed statistically significant improvement as compared to the placebo on several goals after one week.
Axsome said it would file marketing application for AXS-05 in the second half of 2020.
Apart from major depressive disorder, AXS-05 is being tested for treatment-resistant depression and agitation, associated with Alzheimer’s disease. It is also being developed to help people quit smoking.
Axsome shares were trading at $73.14 in early trading.