US regulator needs more safety data for new Auvelity indication

28 February 2023
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New York-based central nervous system (CNS) specialist Axsome Therapeutics (Nasdaq: AXSM) has hit a regulatory snag in the development of AXS-05 (dextromethorphan/bupropion).

The novel oral medicine, an NMDA receptor blocker, boasts  positive Phase III data from the ACCORD trial for the treatment of Alzheimer’s disease (AD) agitation.

However, hopes that a new drug application for AXS-05 in this indication would be possible using results from ACCORD alone have now been set aside.

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