Auvelity, depression drug from Axsome Therapeutics, gets FDA approval

Axsome Therapeutics, Inc. announced the U.S. Food and Drug Administration has approved Auvelity, an oral drug used to treat major depressive disorder in adults. 

The biopharmaceutical company expects the treatment to be commercially available in the U.S. in the fourth quarter of 2022.

Auvelity is claimed to be able to reduce symptoms of depression in one week compared to older antidepressants. 

"The mental health crisis in the United States is one of the most pressing health issues facing our country today," Michael Pollock, Chief Executive Officer of the Depression and Bipolar Support Alliance, said in a news release. "Over 20 million American adults experienced major depressive disorder each year prior to the COVID-19 pandemic. These numbers increased dramatically during the pandemic with approximately thirty percent of adults in the U.S. or more than 80 million Americans experiencing elevated symptoms of depression."

RELATED: 988 hotline to simplify access to emotional distress and suicidal crisis resources

According to the company’s news release, Auvelity was studied in a comprehensive clinical program that included more than 1,100 patients with depression.

According to Reuters, Axsome's therapy targets several neurotransmitters including glutamate and had succeeded in a late-stage trial in 2019. The long-awaited approval for the therapy comes after the agency found deficiencies in the company's application last year and extended its review of the drug.

Depression on the rise across the world

The World Health Organization (WHO) says the global prevalence of anxiety and depression increased by 25% in the first year of the COVID-19 pandemic. The scientific brief released by the United Nations (UN) agency said one explanation for the increase is unprecedented stress caused by the social isolation resulting from the pandemic.

Loneliness, fear of infection, suffering and death for oneself and loved ones, grief following bereavement, and financial worries were all cited as factors leading to anxiety and depression.

WHO also said depression is a common illness worldwide, with an estimated 3.8% of the population affected, including 5.0% among adults and 5.7% among adults older than 60 years. Approximately 280 million people in the world have depression.

RELATED: 988 hotline to simplify access to emotional distress and suicidal crisis resources

Symptoms of depression include depressed mood (feeling sad, irritable, empty) or a loss of pleasure or interest in activities, for most of the day, nearly every day, for at least two weeks, according to WHO. 

If you or a loved one is feeling distressed, call the National Suicide Prevention Lifeline. The crisis center provides free and confidential emotional support 24 hours a day, 7 days a week to civilians and veterans. Call the National Suicide Prevention Lifeline at 1-800-273-8255 (tel:18002738255). Or text HOME to 741-741 (Crisis Text Line).

CLICK HERE ( for the warning signs and risk factors of suicide. Call 1-800-273-TALK for free and confidential emotional support.

This story was reported from Los Angeles.