FDA approves Exxua for depression treatment after multiple rejections over more than two decades 

The U.S. Food and Drug Administration (FDA) on Thursday approved the medication Exxua to treat major depressive disorder – a significant step after a decades-long battle for approval. 

Exxua is unique for its ability to target the serotonin 1A receptor, which is a regulator of mood and emotion. In doing so, it avoids undesirable side effects that often come with drugs that treat anxiety and depression disorders, including sexual dysfunction and weight gain, according to the press release from drug manufacturer Fabre-Kramer Pharmaceuticals. 

Fabre-Kramer described Exxua as inaugurating a “new class of antidepressant” that will be available in pharmacies in 2024. 

“EXXUA represents an important milestone in the treatment of MDD, a serious and debilitating condition that affects millions of people worldwide,” Fabre-Kramer CEO Stephen Kramer said in the press release.

“There is value in providing prescribers and patients with a wide range of effective options for use in clinical practice. We are proud to bring this innovative therapy to patients who need a new option to manage their depression and improve their quality of life,” he continued.

The FDA had previously rejected the drug’s approval twice, reportedly as a result of some failed studies.

The recent studies, according to the pharmaceutical company, were conducted in over 5,000 patients and proved to have “an overall acceptable safety profile, with no significant adverse effect on weight, blood pressure, heart rate or liver function.” 

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Dizziness and nausea were sometimes side effects but they were described as “mild, of short duration, related to dose escalations and did not require discontinuation of treatment.”

The company’s press release included several testimonials from prominent clinicians, researchers and advocates, who lauded the drug as a game changer for patients. 

CEO Michael Pollock of the Depression and Bipolar Support Alliance (DBSA) connected the new drug to the mental health crisis in the country.

“The mental health crisis in the United States is one of the most pressing health issues facing our country today. 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 30% of adults in the US or more than 80 million Americans experiencing elevated symptoms of depression,” he said. 

“The need for new treatment options, particularly those with new mechanisms of action, could not be clearer and more urgent for those living with, or impacted by, major depressive disorder,” Pollack continued.