FDA Approves Ketamine Product, KETARx, for Surgical Pain Management

MONDAY, Aug. 18, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved the ketamine product, KETARx, for use in surgical pain management.

Ketamine is the only psychedelic or psychedelic-adjacent drug on the World Health Organization Essential Medicines List, with its global market projected to grow from $750 million to $3.42 billion by 2034.

PharmaTher, which developed KETARx, believes there is a promising outlook for the ketamine market and that the FDA approval provides a strong foundation for expanding the development of ketamine across diverse therapeutic areas. These areas include depression, neurological disorders (Parkinson disease, amyotrophic lateral sclerosis), and rare or chronic pain conditions.

“Today marks a new chapter for PharmaTher. With FDA approval for ketamine now in hand, we are closer to realizing our goal of becoming a global leader in ketamine-based pharmaceuticals. This historic FDA approval for PharmaTher is a testament to years of dedicated development, signaling a new era of growth,” Fabio Chianelli, founder and CEO of PharmaTher, said in a statement. “We remain steadfast in our mission to harness the pharmaceutical potential of ketamine for a range of mental health, neurological, and pain disorders.”

Approval of KETARx was granted to PharmaTher.

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