Major depressive disorder (MDD) is a common mental health disorder. Recent data from the National Institute of Mental Health (NIMH) reports that around 8.4% of adults in the United States, approximately 21 million people, had at least one major depressive episode in the year 2020. And while the same NIMH report found that 66% of adults who experienced a major depressive episode received treatment, many individuals fail to respond to current treatments for MDD.
Current estimates find that 1/3 of people show resistance to treatments for MDD and fail to respond. Of patients that do respond to treatment, therapeutic effects may take a long time to take effect. For most current depression drugs, it can take up to 2-3 weeks to see an initial improvement and up to 6 months for remission – or for symptoms to improve to the point that an individual is no longer considered “depressed.” Altogether, current drug treatments for depression may take weeks to months to be effective. However, last week, the biopharmaceutical company Axsome Therapeutics received approvalfrom the United States Food and Drug Administration (FDA) for their new fast-acting anti-depressant drug.
The FDA-approval is for Axsome’s drug called Auvelity (dextromethorphan HBr and Bupropion HCl). The drug is the first and only rapid-acting oral medication that has been FDA-approved for the treatment of MDD. Additionally, Auvelity is the first and only approved oral medication that acts as a N-methyl D-aspartate (NMDA) antagonist. Ketamine has been a large focus of NMDA-receptor antagonism for the treatment of psychiatric disorders. But Axsome has focused on dextromethorphan (a product in many cough medications) as an NMDA antagonist in combination with bupropion (brand name Wellbutrin) to treat depression.
The fast-acting nature of Auvelity is what sets the drug apart from other drugs currently on the market. The approval from the FDA was based on recent data from two separate clinical trials. In the first study, 1,100 patients with MDD took Auvelity or a placebo. Patients who were provided with Auvelity showed a statistically significant improvement in depressive symptoms at the end of the first and second week of the study compared to the Placebo group. Similar findings were reported in the second clinical trial which compared patients given Auvelity to patients given bupropion alone. As Lori Englebert, Axsome’s Executive Vice President said, “With symptom improvement happening at week one and then remission happening by week two, the combination of those two is incredibly differentiating in the marketplace right now.”
Axsome is planning to make this much needed medication commercially available by the end of the year. And while individual differences in drug response and some side effects may limit the treatment response for some, the drug is promising. Herriot Tabuteau, CEO of Axsome said, “We are extremely proud to deliver this Breakthrough Therapy-designated new treatment to the millions of patients living with depression at a time when it is most needed, given the recent sharp increase in depression prevalence.”