Fabre-Kramer Pharmaceuticals’ major depressive disorder drug, gepirone, faced FDA rejection not once, not twice, but three times since the beginning of the 21st century. Finally, the company can rejoice as the FDA has granted long-awaited approval. On 29 September 2023, the FDA approved Fabre-Kramer Pharmaceuticals’ extended-release gepirone hydrochloride tablets, branded as EXXUA, for major depressive disorder treatment in adults. This privately-held company claims that Exxua is the “first and only approved” antidepressant for major depressive disorder treatment in adults, acting through selective 5HT1a receptor agonism to modulate serotonin activity in the central n...
