The FDA’s decision on Axsome Therapeutics’ Auvelity is based on positive results from a massive clinical program that covered over 1,100 patients with depression.
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The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for this indication.
Auvelity (dextromethorphan HBr -bupropion HCl) is an extended-release tablet that uses the first new oral mechanism of action in over 60 years for MDD. Its dextromethorphan content works on the NMDA receptor, an ionotropic glutamate receptor, and the sigma-1 receptor in the brain, while the bupropion component helps increase dextromethorphan blood levels by inhibiting cytochrome P450 2D6.
The product is patented, extending at least to 2037-2040, and is expected to be commercially available by the fourth quarter in the U.S. It is not approved for use in children.
The FDA’s decision is based on positive results from a large clinical program that covered over 1,100 patients with depression. The GEMINI placebo-controlled trial established the drug’s efficacy, which was further supported by results from the ASCEND trial, which showed Auvelity’s superiority compared to bupropion sustained-release tablets.
Dan V. Iosifescu, M.D., professor of psychiatry at the New York University School of Medicine and director of the clinical research division at the Nathan Kline Institute for Psychiatric Research, said Auvelity can begin working as early as one week after starting treatment.
“In clinical trials, Auvelity has demonstrated rapid and statistically significant improvement in depressive symptoms as early as Week 1, and increased rates of remission at Week 2 compared with placebo. This early benefit with Auvelity was maintained and increased with continued treatment, and was accompanied by a favorable safety and tolerability profile,” Iosifescu added.
Auvelity received a breakthrough therapy designation for MDD from the FDA in March 2019. Its new drug application (NDA) was evaluated under priority review.
Michael Pollock, CEO of the Depression and Bipolar Support Alliance, stated that more than 20 million American adults experienced major depressive disorder every year before the pandemic hit. During the pandemic, around 30% of adults, or approximately 80 million people, reported experiencing elevated depressive symptoms in the U.S. alone.
Patients starting on Auvelity will have support through the Auvelity On My Side program, which provides financial assistance through a savings card for eligible commercially-insured individuals. All support resources will be available upon the product’s launch.
