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Aytu BioPharma Announces Commercial Availability of EXXUA(TM) (gepirone) Extended-Release Tablets, the First and Only 5HT1a Agonist Indicated for the Treatment of Major Depressive Disorder in Adults
EXXUA is now available through Aytu RxConnect® pharmacies to ensure optimal access and availability EXXUA has demonstrated significant improvement in depression symptoms in clinical trials involving more than 5,000 patients and, notably, has no ...
About this update from Aytu Biopharma, Inc.
[{"type":"text","content":"EXXUA is now available through Aytu RxConnect® pharmacies to ensure optimal access and availability","length":107,"tagName":"p"},{"type":"text","content":"EXXUA has demonstrated significant improvement in depression symptoms in clinical trials involving more than 5,000 patients and, notably, has no warnings or adverse events related to sexual dysfunction and no clinically significant weight gain compared to placebo","length":263,"tagName":"p"},{"type":"text","content":"DENVER, CO / ACCESS Newswire / December 15, 2025 / Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, today announced the commercial availability of EXXUA in the United States. EXXUA is the first and only 5HT1a agonist approved by the United States Food and Drug Administration for the treatment of major depressive disorder ("MDD"), representing a new way to treat MDD.","length":567,"tagName":"p"},{"type":"text","content":"The immediate availability of EXXUA through participating Aytu RxConnect pharmacies enables patients and prescribers the ability to access EXXUA through Aytu's best-in-class patient access program, Aytu RxConnect. In parallel, distribution through all major United States wholesalers is progressing to enable nationwide availability across all pharmacy retailers in the coming weeks. Product information and Aytu RxConnect pharmacy availability can be found at EXXUA.com.","length":475,"tagName":"p"},{"type":"text","content":""We are thrilled to have achieved this significant milestone with EXXUA now officially available in the United States as a new treatment option for the estimated 21 million Americans suffering from major depressive disorder," commented Josh Disbrow, Chief Executive Officer of Aytu. "EXXUA represents a truly unique approach to treating MDD, offering a novel mechanism of action and distinctive clinical profile - including the absence of reported sexual side effects in clinical trials. We are excited to see EXXUA entering the commercial channel across the United States, supported by full integration into Aytu RxConnect patient platform. Ensuring that patients who need EXXUA can access it remains our top priority,...