PharmaTher’s KETARx becomes first FDA-approved ketamine formulation for on-label surgical use
In a historic regulatory milestone, the FDA approved PharmaTher’s KETARx on August 8, 2025, marking the first on-label approval of ketamine specifically for surgical pain management and ending decades of off-label use in perioperative settings.
The approval represents a significant clinical innovation in pain management, particularly as healthcare systems seek alternatives to opioid-dependent protocols. Ketamine’s unique mechanism as an NMDA receptor antagonist provides both anesthetic and analgesic properties while potentially reducing opioid requirements.
Development Journey: PharmaTher overcame two previous FDA rejections before achieving this breakthrough approval. “This historic FDA approval is a testament to years of dedicated development,” said Fabio Chianelli, the company’s chairman and CEO.
The significance extends beyond a single product approval. Ketamine has long been recognized on the WHO Essential Medicines list, yet lacked proper FDA-backed formulations for pain management applications outside of its established anesthetic uses.
Market Opportunity: With millions of surgical procedures performed annually in the US, and growing emphasis on multimodal pain management strategies, KETARx addresses substantial market demand. The approval validates commercial potential for repurposing well-characterized molecules with optimized formulations.
Commercial Launch: PharmaTher previously indicated it was fully funded through FDA approval and commercial launch preparations. The company now enters a market where ketamine’s established safety profile and unique pharmacology position it as a valuable addition to perioperative pain management protocols.
The approval opens new possibilities for ketamine-based medicines across multiple therapeutic areas, building on recent successes in treatment-resistant depression and other psychiatric applications.
