A company working on treatments for people with mental health issues has had positive feedback from the development program of an anti-depressant targeting major depressive disorder (MDD).
ANeuroTech has just announced that after a successful pre-Investigational New Drug Application (IND) meeting, the US Food and Drug Administration (FDA) has given positive feedback on its pivotal phase 3b development program of ANT-01 as an adjunctive anti-depression drug for MDD.
The ability to feel pleasure, used as a measure for the first time, and an improvement in cognitive function, have been included as a secondary endpoint in the phase 3b part of the clinical trial.
ANeuroTech will file for IND in the fourth quarter and apply for FDA Fast-Track Designation at the same time.
More than 60% of people with depression and associated cognitive problems are not helped by initial treatments or experience challenging side-effects.
ANeuroTech is developing ANT-01 as an adjunctive anti-depression drug with minimal or no side-effects. It is a low dose of an existing drug substance,
The post Positive news from trial for drug to treat major depressive disorder appeared first on Labiotech.eu.
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