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 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.
(Reporting by Vishwadha Chander in Bengaluru; Editing by Vinay
Dwivedi)
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