The biopharma Axsome Therapeutics (Nasdaq:AXSM) has won FDA approval for Auvelity (dextromethorphan HBr-bupropion HCl) extended-release tablets for treating major depressive disorder (MDD) in adults.
Auvelity is the only rapid-acting oral medicine for MDD with labeling describing statistically significant antidepressant efficacy at one week. Clinical trial data also show that the drug maintains efficacy at week 6.
Axsome Therapeutics concludes that the drug represents the first new mode of action for MDD in more than 60 years.
The company also notes that the drug is the only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for MDD.
“It is important to highlight that MDD is a serious, chronic, disabling and even life-threatening condition with very high rates of morbidity and mortality,” said NYU Langone psychiatrist Dr. Dan Iosifescu in an Axsome webinar. “The morbidity seen in patients with MDD includes profound distress, inability to work and impaired social functioning.”
While the prevalence of depression has increased during the pandemic, many patients remain frustrated with currently available treatment options. Almost two-thirds, 63%, fail to achieve remission after initial pharmacotherapy, Iosifescu said.
According to Axsome research, 78% of MDD patients were frustrated with at least one treatment for the condition.
One of the most popular classes of antidepressants, SSRIs, can take between six to eight weeks to be effective. Many SSRIs have efficacy that is marginally better than placebo.
“Very importantly, all currently approved oral agents for major depressive disorder work primarily through monoaminergic mechanisms,” Iosifescu said. “This is a very important point to consider, as it may explain the high rates of inadequate response with current treatments for major depressive disorder.”
Auvelity is an oral N-methyl-D-aspartic acid (NMDA) receptor antagonist, sigma-1 receptor agonist and glutaminergic-modulating treatment.
In a placebo-controlled Phase 3 study, the drug was generally well tolerated and led to statistically significant reductions in the Montgomery-Asberg Depression Rating Scale (MADRS).
Auvelity has patent protection extending out to at least 2037.
While the drug has a proprietary formulation, the two compounds in Auvelity are not new.
Dextromethorphan is a widely used OTC cough suppressant.
Bupropion is a smoking-cessation drug with a history of use as an antidepressant. With the trade name Wellbutrin, the drug won FDA approval as an antidepressant in 1985.
Auvelity aims to commercialize the drug in the fourth quarter of 2022.
The company has yet to determine the pricing of the drug.
AXSM shares jumped 59.55.