The European Medicines Agency (EMA) has not yet approved Auvelity for use in Europe. The drug, developed by Axsome Therapeutics, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) [1].
What is Auvelity and How Does it Work?
Auvelity is an oral medication for major depressive disorder that combines dextromethorphan and bupropion. Dextromethorphan is a low-affinity uncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and an agonist of sigma-1 receptors. Bupropion is an inhibitor of norepinephrine and dopamine reuptake [1].
What is the Timeline for Potential European Approval?
Axsome Therapeutics has stated its intention to pursue international development and commercialization of Auvelity, including seeking approval in Europe. However, no specific timeline for an EMA submission or approval has been announced [1].
How Does Auvelity Compare to Other Depression Treatments?
Auvelity offers a novel dual mechanism of action for MDD, distinct from traditional selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Clinical trials have demonstrated its efficacy in improving depressive symptoms [1].
What are the Risks and Side Effects of Auvelity?
Common side effects reported in clinical trials include dizziness, nausea, headache, diarrhea, insomnia, dry mouth, and decreased libido. Auvelity carries a boxed warning for the risk of suicidal thoughts and behaviors. It also has potential drug interactions due to its components [1].
Who is Developing Auvelity?
Auvelity is developed by Axsome Therapeutics, a biopharmaceutical company focused on therapies for central nervous system disorders [1].