Picture this: The FDA has approved a C-III med for POST SURGICAL PAIN, but farther down the article the company is talking about using it to treat high acuity chronic health issues

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.

I can sense that the DEA is going to be watching this expansion of the use past acute post surgical pain.  I can remember when Talwin, Stadol, Ultram came to market as a non-addicting med for pain, and it wasn’t long that all three were a CONTROLLED SUBSTANCE.

Then there was Lyrica – a gabapentin class of med – and I was told that 1 or 2 people in the clinical trials stated that it “made them high” and DEA could let that go by without some action and made it a C-5 Controlled Substance. Adding Lyrica as a C-5 increased the total number of C-5 by abt 20%, because there are so few C-5 meds.

There is little info on this “new med” but all the rest of the Ketamine based meds is injectable. With some pharmacy compounded nasal sprays and sub-lingual/buccal trochee. 

I also have “the sense” that this medication may well end up being distributed thru restricted distribution via “specialty pharmacies” , which tend to be FAIRLY EXPENSIVE MEDS. Fairly expensive meds that are being promoted in treating high acuity chronic health issues, most insurance companies won’t want to pay for them.

FDA Okays Ketamine-Based Med for Post-Surgical Pain

https://www.medscape.com/viewarticle/fda-okays-ketamine-based-med-post-surgical-pain-2025a1000la0

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.

Filed under: General Problems