Author: Brauser D
Medscape Medical News
The FDA has approved KETARx, a racemic ketamine formulation developed by PharmaTher Holdings, for the treatment of post-surgical pain. This marks a significant regulatory milestone for ketamine, which remains the only psychedelic or “psychedelic-adjacent” compound included on the World Health Organization’s list of Essential Medicines.
PharmaTher has indicated plans to pursue broader development of KETARx for neurological and psychiatric conditions, including Parkinson’s disease, ALS, depression, complex regional pain syndrome, and Rett syndrome (for which it has orphan drug designation).
The approval followed a delayed process: the FDA originally set an April 2024 goal date, later revised to October 2024 after a complete response letter cited quality deficiencies. A final approval date was granted in August 2025 after the company submitted the necessary supplemental data.
Key Takeaways
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KETARx (racemic ketamine) is FDA-approved for post-surgical pain.
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It is the only psychedelic-related drug on the WHO Essential Medicines list.
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PharmaTher plans expansion into neurologic and psychiatric indications, including Rett syndrome.
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The approval process faced delays due to FDA quality concerns, resolved with additional submissions.
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The decision reinforces ketamine’s clinical relevance beyond anesthesia into chronic and rare conditions.
Thank you to Medscape Medical News for reporting on this FDA approval and its broader implications for ketamine-based therapies.