Lumanity Provides Strategic and Tactical Regulatory Support for FDA Approval of EXXUA™ for the Treatment of Major Depressive Disorder in Adults

Announcements Oct 12, 2023

Lumanity applauds Fabre-Kramer Pharmaceuticals Inc. for their achievement in securing FDA approval for EXXUA™ (gepirone hydrochloride extended-release tablets), for the treatment of major depressive disorder (MDD) in adults. Clinical studies have demonstrated EXXUA’s distinct mechanism, which focuses on single serotonin 1A receptor agonism, to be both effective in alleviating depressive symptoms and well-tolerated in terms of side effects. EXXUA™ is expected to be available in pharmacies in early 2024.

Having provided strategic and tactical regulatory support for Fabre Kramer for over a decade, Lumanity is honored to have played a role in introducing this groundbreaking class of antidepressant to the medical community and, more importantly, to the patients who need it most.

“Lumanity’s Clinical and Regulatory team were there for us every step of the way; we couldn’t have gotten this important drug to the finish line without them.”

Stephen Kramer, M.D., CEO, Fabre-Kramer

“I am impressed with Fabre-Kramer’s tenacious, evidence-based, multi-faceted journey over the last twenty years; we are honored to have played a role in bringing such a unique compound to market. Based on this drug’s unique mechanism of action, its well demonstrated antidepressant benefits, and lack of sexual side effects, this drug is well positioned to provide a new and innovative approach to the treatment of depression. We look forward to working with Fabre-Kramer on future research that explore and elucidates the benefits of this important molecule.”

Steven Weisman, PhD, Global President of Clinical and Regulatory, Lumanity

Lumanity is a global strategic services partner built to effectively blend deep scientific, clinical, medical, regulatory and commercial expertise to support complex client decision-making and execution throughout the asset value creation and demonstration journey.

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Read more on EXXUA™ and Fabre-Kramer’s full press release here.