Aytu BioPharma launches EXXUA depression drug nationwide

January 20, 2026 9:01 AM EST

Aytu BioPharma Inc. (NASDAQ: AYTU) announced the nationwide commercial launch of EXXUA (gepirone), a depression medication that received FDA approval for treating major depressive disorder in adults. The company completed its launch meeting and sales training preparations.

EXXUA represents the first selective 5-HT1A receptor agonist approved by the FDA for major depressive disorder treatment. The once-daily medication targets specific serotonin receptors while minimizing activity at receptors linked to sexual dysfunction and weight gain, which are common side effects of traditional antidepressants.

According to the company, up to 70% of the 21 million Americans with major depressive disorder experience sexual dysfunction from current treatments, while more than 65% are affected by weight gain. These side effects drive nearly half of patients to discontinue their treatment.

"Completing our EXXUA launch meeting marks a significant milestone for Aytu as we transition from preparation to execution," said Josh Disbrow, CEO of Aytu BioPharma.

The medication is available through retail pharmacies and participating Aytu RxConnect pharmacies. EXXUA carries FDA warnings about increased risk of suicidal thoughts and behaviors in pediatric and young adult patients, and the drug is not approved for pediatric use.

The medication also prolongs the QTc interval and requires electrocardiogram monitoring before and during treatment. Common adverse reactions include dizziness, nausea, insomnia, abdominal pain, and dyspepsia.

Aytu BioPharma focuses on treatments for central nervous system disorders and attention-deficit/hyperactivity disorder. The information is based on a company press release.



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