Following the news that Axsome Therapeutics’ Auvelity (dextromethorphan + bupropion) has been approved by the FDA for the treatment of major depressive disorder (MDD) in adults;

Pippa Salter, Senior Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“Auvelity’s rapid onset of action will provide a major breakthrough to the MDD market, in which there exists a significant unmet need for pharmacotherapies that can demonstrate rapid antidepressant effects.

“The rapid and sustained antidepressant effects of Auvelity are expected to result in strong uptake for the drug and, by targeting the N-methyl D-aspartate (NMDA) receptor, it will also provide a novel mechanism of action for the significant proportion of MDD patients with poor responses to the current treatment options. As such, GlobalData forecasts strong global sales of $1.3 billion by 2029.

“Weight gain is one of the most undesirable side effects of current antidepressants as highlighted by key opinion leaders interviewed previously by GlobalData. Since treatment with Auvelity was not associated with weight gain in clinical trials, the drug could be a more appealing long-term option to patients, resulting in increased compliance compared with other antidepressants, likely boosting its overall efficacy.

“Despite the advantages of Auvelity, there could still be some challenges for this new product. Although Axsome has not yet announced a price, GlobalData anticipates it to be a comparatively expensive product compared with cheap, generic selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs), which are very well established in the MDD market. With an expected price of over $1,000 per year, Auvelity may see its use restricted to second and later lines of therapy, after cheaper alternatives have been trialled, which would limit potential revenue.”