Axsome Therapeutics depression drug AXS-05 meets goal in late-stage trial

The trial results of Axsome Therpeutics' oral tablet, AXS-05 takes the company a step closer to acquiring a share of the multi-billion dollar market for depression drugs, the company said.

New Delhi: Axsome Therapeutics Inc said on Monday its drug succeeded in reducing symptoms of major depressive disorder in a late-stage trial, sending the company's share soaring 56% before the bell.

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.

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Axsome said it would file a marketing application for AXS-05 in the second half of 2020.

Apart from a 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.

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