Aytu BioPharma has announced an exclusive agreement with Fabre-Kramer Pharmaceuticals to commercialise Exxua (gepirone) extended-release tablets in the US.
Exxua is a first-in-class selective serotonin 5HT1a receptor agonist that has been approved by the US Food and Drug Administration (FDA) for major depressive disorder (MDD).
Under the terms of the agreement, Aytu paid Fabre-Kramer Pharmaceuticals an upfront payment and will make an additional fixed payment one year after the launch of Exxua.
Fabre-Kramer will also receive royalties on net revenue, a product transfer price, and performance-based milestone payments.
The transaction is funded by available cash and a financing round led by healthcare-focused institutional investors.
The investors include Nantahala Capital Management and Stonepine Capital Management, along with Aytu’s management and new institutional shareholders.
Fabre-Kramer Pharmaceuticals co-founder and CEO Stephen Kramer 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 practising 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.”
Aytu is preparing to launch Exxua in the US, with pharmacy and patient availability expected in the fourth quarter of 2025.
Exxua is not a selective serotonin reuptake inhibitor, and does not exhibit reuptake inhibition activity, with no adverse effects on weight, blood pressure, heart rate, or liver function.
The antidepressant has been studied in over 5,000 patients and introduces a new class of therapeutics in the US prescription MDD market.
Furthermore, Exxua does not carry label warnings about the risk of sexual dysfunction, differentiating it from other antidepressants.
Its mechanism involves modulating serotonin activity, specifically binding to 5HT1a receptors, which regulate mood and emotion.
Aytu BioPharma CEO Josh Disbrow said: “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 centrepiece 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.”
“Aytu is well-positioned to realise 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.”
