The US FDA Approves Axsome Therapeutics Inc’s (NASDAQ: AXSM) AUVELITY For MDD Treatment

Axsome Therapeutics Inc (NASDAQ: AXSM) has announced that the US FDA has cleared AUVELITY extended-release tablets for major depressive disorder in adults.

AUVELITY is the only quick-acting medication approved for MDD

AUVELITY is currently the only and the first rapid-acting oral medication to receive approval for MDD treatment, labeling meaningful antidepressant efficacy relative to placebo after one week. At every successive time point, AUVELITY’s potent antidepressant benefits persisted. For MDD treatment, AUVELITY is the inaugural and sole oral N-methyl D-aspartate (NMDA) selective inhibitor to receive approval. In the Q4 of 2022, Axsome expects AUVELITY to be accessible in the market across the United States.

Maurizio Fava, Psychiatrist-In-Chief, Department of Psychiatry at Massachusetts General Hospital stated, “The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile. Auvelity, which was granted Breakthrough Therapy designation by the FDA, represents the first new oral non-monoamine-based mechanism of action approved to treat the major depressive disorder in over sixty year.”

AUVELITY received Breakthrough Therapy Designation in 2019

Over two-thirds of people don’t respond sufficiently to the currently available antidepressants in the market, and those who do may take up to six or eight weeks to experience clinically significant improvements. The effectiveness of Auvelity shown after a week and maintained afterward might substantially influence the existing treatment approach for this disorder, given the crippling nature of depression.

In March 2019, the FDA designated AUVELITY as a Breakthrough Therapy for the management of MDD. According to initial clinical data, such a designation is given to product candidates with prospects to provide benefits above and beyond those of currently available therapies. In addition, it allows the sponsor of the drug candidate to receive additional attention and communicate with FDA employees throughout the candidate drug’s advancement. Accordingly, the FDA evaluated the AUVELITY New Drug Application (NDA) on Priority Review.