The FDA has approved the racemic ketamine product known as KETARx (PharmaTher Holdings) for the treatment of post-surgical pain.
“This historic FDA approval…is a testament to years of dedicated development,” Fabio Chianelli, chairman and CEO of PharmaTher, said in a release.
“We remain steadfast in our mission to harness the pharmaceutical potential of ketamine for a range of mental health, neurological, and pain disorders,” he added.
The company noted that it hopes to expand ketamine development into conditions such as Parkinson’s disease, amyotrophic lateral sclerosis, depression, and complex regional pain syndrome. Its product has already received an orphan drug designation for the treatment of Rett syndrome.
It added that, among psychedelic and “psychedelic-adjacent” drugs, ketamine is the only one to be included on a list of Essential Medicines by the World Health Organization.
The company initially announced that the FDA had set an approval goal date of April 2024 for KETARx. However, after “minor deficiencies identified by Quality” were identified, the FDA assigned a new target date of October 2024. As reported by Medscape Medical News at the time, the FDA issued a complete response letter requesting additional information on the application.
The final date of August 2025 was set after the company submitted the requested additional information.
Source link : https://www.medscape.com/viewarticle/fda-okays-ketamine-based-med-post-surgical-pain-2025a1000la0?src=rss
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Publish date : 2025-08-11 18:59:00
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