FDA Approved AUVELITY for Major Depressive Disorder in Adults

On August 19, 2022, the FDA approved AUVELITY — an oral medication manufactured by Axsome Therapeutics — for the treatment of major depressive disorder (MDD) in adults. This medication provides an additional option for those struggling with MDD who may not be able to use other antidepressants.

The National Institute of Mental Health (NIMH), using information from the DSM-5, defines a major depressive episode as “a period of at least two weeks when a person experienced a depressed mood or loss of interest or pleasure in daily activities, and had a majority of specified symptoms, such as problems with sleep, eating, energy, concentration, or self-worth.”

The NIMH states that, among adults in the United States, approximately 21 million have experienced one or more major depressive episodes. Females experience major depressive episodes at a 4.3% higher rate than males. Between 18 and 25 is the age bracket with the highest prevalence at 17%. Additionally, people of multiracial backgrounds also have an increased prevalence of major depressive episodes.

According to the press release by Axsome, “AUVELITY is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week.”

This approval considered data from the GEMINI placebo-controlled study, which included 1,100 participants with depression. Throughout the study, patients taking AUVELITY had a significantly improved Montgomery–Åsberg Depression Rating.

AUVELITY is an NMDA receptor antagonist that is delivered orally. On a chemical level, the pill is an extended-release pill that combines 45 mg of dextromethorphan HBr and 105 mg of bupropion HCl.

The recommended dosing regimen is one pill a day for three days, at which point the dose can be increased to two capsules a day with a minimum of eight hours between each dose. AUVELITY is available by prescription only.

Potential side effects of the medication can include seizures, hypertension, manic episodes, vision problems, dizziness, and more.

“Major depressive disorder is disabling and potentially life-threatening, causes profound distress for patients and their families, and leads to substantial healthcare resource utilization. Auvelity’s oral NMDA receptor antagonist and sigma-1 receptor agonist activity, which targets glutamatergic neurotransmission, provides clinicians a long sought-after new mechanistic approach which may benefit the millions of patients living with this serious condition,” stated Dan V. Iosifescu, MD, Professor of Psychiatry at the New York University School of Medicine, and Director of the Clinical Research Division at the Nathan Kline Institute for Psychiatric Research in the axsome press release.