The US Food and Drug Administration (FDA) has approved Axsome Therapeutics Auvelity (dextromethorphan and bupropion) for the treatment of adult patients with major depressive disorder.
Auvelity is claimed to be the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist with multimodal activity approved for the treatment of the major depressive disorder.
It is said to be the only rapid-acting oral drug for major depressive disorder, which has been shown to significantly reduce depression in one week compared to a placebo.
Axsome said Auvelity uses the first new oral mechanism of action that has been approved for major depressive disorder in more than 60 years. The drug is expected to become commercially available in the US in the fourth quarter of this year.
In March 2019, Auvelity received a breakthrough therapy designation from the FDA for the treatment of the major depressive disorder.
Harriet Tabuto, CEO of Axsome, said: “The acceptance of Auvality is the culmination of tremendous and focused research and development activities conducted by the Axsome team and our partners”. “We are extremely proud to have delivered this new treatment, named Breakthrough Therapy, to the millions of patients living with depression at a time when it is most needed, given the recent sharp increase in depression prevalence”.
Auvelity was evaluated in a comprehensive clinical program and its efficacy in the treatment of major depressive disorder patients was shown in the Gemini placebo-controlled study. The drug demonstrated a statistically significant superiority in improving symptoms of depression compared to the placebo in the GEMENI study.