Aytu BioPharma, Inc. announced the signing of an exclusive agreement to commercialize EXXUA (gepirone) extended-release tablets (“EXXUA”) in the United States. Gepirone is a new chemical entity, and EXXUA is the first-in-class selective serotonin 5HT1a receptor agonist approved by the United States Food and Drug Administration (“FDA”) for the treatment of MDD in adults.
EXXUA has been extensively studied in over 5,000 patients and represents a new class of therapeutics to compete in the over $22 billion United States prescription MDD market. Importantly, EXXUA is the only antidepressant acting on serotonin receptors that does not carry label warnings about the risk of sexual dysfunction. The mechanism of the antidepressant effect of EXXUA is believed to be related to its modulation of serotonin activity and, specifically, its exclusive and strong binding affinity for 5HT1a receptors, which are key regulators of mood and emotion. EXXUA is not a selective serotonin reuptake inhibitor (“SSRI”) and has no reuptake inhibition activity. EXXUA also exhibits no significant adverse effects on weight, blood pressure, heart rate or liver function.
Dr. Stephen Stahl, Professor of Psychiatry, University of California and founder of the Neuroscience Education Institute, a recognized expert neuropsychopharmacologist said “EXXUA is the first truly selective agonist of the serotonin 1a receptor that has been consistently linked to mediation of mood disorders and suicide risk. It’s an important addition to the armamentarium to treat depression.”
Josh Disbrow, Chief Executive Officer of Aytu, stated, “We are thrilled to be the exclusive commercialization partner for EXXUA in the United States and to be partnering with Fabre-Kramer Pharmaceuticals on this exciting opportunity. We believe that the licensing of EXXUA represents a transformative milestone for Aytu and a significant advancement for patients suffering from major depressive disorder.”
“Over the past two years, Aytu has undergone a planned, strategic pivot to focus on our core prescription business while seeking to acquire differentiated, branded CNS products that complement our portfolio and focus. We believe that EXXUA is a perfect strategic fit and will be a centerpiece of Aytu’s commercial efforts going forward considering the significant commercial potential, uniqueness of the product, our sales force’s CNS focus and alignment with our proprietary Aytu RxConnect patient access platform,” Disbrow continued.
“More importantly, given the compelling and novel product profile of EXXUA and the unmet needs of MDD patients, we believe EXXUA can become a very important treatment option for the over 21 million Americans affected by MDD. Over 340 million antidepressant prescriptions were written in 2024 in the United States, yet significant unmet needs remain considering the unacceptable side effects associated with current therapeutics. Aytu is well positioned to realize the significant market potential of EXXUA while positively impacting the lives of MDD patients. We look forward to launching EXXUA later this year and to our exciting partnership with Fabre-Kramer Pharmaceuticals,” Disbrow concluded.
Stephen Kramer, M.D., Co-Founder and Chief Executive Officer of Fabre-Kramer Pharmaceuticals said, “We are very pleased to be partnering with Aytu to bring EXXUA to the United States market. We developed EXXUA to address important unmet needs that I witnessed first-hand managing MDD patients for decades as a practicing psychiatrist. While therapeutic advancements have been made, issues such as treatment emergent sexual dysfunction and weight gain persist as problematic side effects of many MDD treatments. We believe EXXUA will be a very important addition to physicians managing the millions of patients with depression in the United States and worldwide.”
Under the terms of the agreement, upon closing Aytu paid Fabre-Kramer Pharmaceuticals an upfront payment and will pay an additional fixed payment at the one-year anniversary of the EXXUA launch date.
In addition, Aytu will pay royalties on net revenue as defined in the definitive agreement, along with a product transfer price. Aytu will also make variable, performance-based milestone payments to Fabre-Kramer Pharmaceuticals upon the achievement of various net revenue thresholds over the term of the agreement.
The EXXUA transaction is being funded by cash on hand along with a financing led by long-term, healthcare-focused institutional investors, including Aytu’s largest shareholder Nantahala Capital Management, Stonepine Capital Management, Aytu management, and new institutional shareholders.
Aytu is actively preparing to launch EXXUA in the United States as soon as possible and currently anticipates pharmacy and patient availability in the fourth calendar quarter of 2025.