Aytu BioPharma Announces Commercial Availability of EXXUA in the United States
On December 15, 2025, Aytu BioPharma Inc. (NASDAQ: AYTU) announced that its first and only 5‑HT₁A agonist, EXXUA® Extended‑Release Tablets, has become commercially available in the United States. The product is intended for the treatment of major depressive disorder (MDD) in adults.
Key Details of the Launch
| Item | Information |
|---|---|
| Drug | EXXUA® Extended‑Release Tablets |
| Indication | Major depressive disorder in adults |
| Mechanism | 5‑HT₁A agonist |
| Approval | FDA‑approved, first and only 5‑HT₁A agonist for MDD |
| Commercial Availability | Beginning December 15, 2025 |
| Distribution Channels | 1) Aytu RxConnect® pharmacies – a patient‑access program that ensures immediate availability; 2) U.S. wholesalers – distribution progressing to enable nationwide availability across all major pharmacy retailers in the coming weeks |
| Clinical Evidence | Clinical trials involving more than 5,000 patients demonstrated significant improvement in depression symptoms. No warnings or adverse events related to sexual dysfunction were reported, and no clinically significant weight gain was observed compared with placebo. |
Significance for Patients and Prescribers
The launch of EXXUA offers a new therapeutic option for patients with MDD, addressing an unmet need for antidepressants that do not carry risks of sexual dysfunction—a common adverse effect that can limit adherence to treatment. By leveraging Aytu’s RxConnect program, patients and prescribers can access the drug directly through participating pharmacies, while the planned wholesale distribution will expand reach to all U.S. pharmacies in the near term.
Company Context
Aytu BioPharma is a specialty healthcare company listed on the Nasdaq. Its portfolio focuses on acquiring, developing, and commercializing products for sexual dysfunction disorders, urological cancer, urinary tract infections, and male infertility. The company’s recent market performance shows a close price of $2.30 as of December 11, 2025, with a 52‑week high of $2.82 and a low of $0.95. Aytu’s market capitalization stands at approximately $23.4 million, and its price‑earnings ratio is currently negative at –1.2.
Outlook
The commercial availability of EXXUA expands Aytu’s presence in the central nervous system therapeutic area, complementing its existing focus on urological and sexual health indications. The company’s strategy of integrating patient‑access programs with traditional wholesale channels aims to maximize market penetration and improve patient outcomes for MDD.
