FDA Approves Ketamine for Surgical Pain Management

The FDA approved ketamine (Ketarx; PharmaTher Holdings) for its indicated uses in surgical pain management, according to a news release from the manufacturer. This indication represents a significant commercial and clinical innovation in the mental health, neurological, and pain disorder spaces.¹

Image credit: Postmodern Studio | stock.adobe.com

Ketamine stands out among psychedelic and psychedelic-adjacent therapies because it is the only one included in the World Health Organization’s Model List of Essential Medicines. Along with esketamine (Spravato; Janssen Pharmaceuticals), a formulation of ketamine administered via nasal spray, it is predicted that the global ketamine market is anticipated to experience significant growth following this approval.^1,2

Further, this action provides a strong foundation to expand the development of ketamine across other therapeutic areas. Currently, these areas include depression and certain neurological and movement disorders (eg, Parkinson disease and amyotrophic lateral sclerosis), as well as the management of rare or chronic pain (eg, complex regional pain syndrome).^1,2

This action follows a resubmission of a new drug application for Ketarx. Initially, the FDA issued complete response letters on October 22, 2024, and April 18, 2024, citing deficiencies classified as “minor,” and requested that the manufacturer address these with new and updated information and clarifications related to the drug substance, drug product, manufacturing, and microbiology. Notably, the FDA did not express concern about the stability of the Ketarx submission batches, nor were new preclinical and clinical studies requested. In October, the FDA requested that the manufacturer resubmit for approval by the end of February 2025.³

Since February 2018, ketamine has been regularly listed on the FDA’s drug shortage list, highlighting a significant need for a consistent and high-quality supply. Additionally, this issue is cautioned by a compounding risk alert issued by the FDA on October 10, 2023, which detailed potential risks that are associated with compounded ketamine products used for the treatment of psychiatric disorders.¹

There has also been emphasis on the importance of expanding research and ensuring legal access to psychedelic therapies for veterans. The Veterans Health Administration—which is the largest integrated healthcare system in the US—currently approves and funds ketamine infusions for retired military personnel afflicted with depression, post-traumatic stress disorder, and chronic pain.¹

Of note, the manufacturer has also submitted investigational new drug applications for ketamine indications in neurological conditions—including Parkinson disease—as well as for new delivery systems (eg, on-body wearable pump, microneedle patch) outside of the intranasal and subcutaneous formulations. A randomized, double-blind, active, placebo-controlled phase 2 clinical trial (NCT04912115)⁴ determined that subanesthetic intravenous infusions of ketamine had reduced dyskinesia that was induced by levodopa in patients with Parkinson disease. Even though ketamine was effective and considered well-tolerated, the ClinicalTrials.gov page currently notes that the trial was suspended earlier than its original estimated completion date of March 30, 2024, with unclear future perspectives.^4,5

“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 [Ketarx] is a testament to years of dedicated development, signaling a new era of growth. We remain steadfast in our mission to harness the pharmaceutical potential of ketamine for a range of mental health, neurological, and pain disorders,” Fabio Chianelli, founder, chairman, and CEO of PharmaTher, said in a news release.¹

REFERENCES

1. PharmaTher. PharmaTher Announces FDA Approval of Ketamine (KETARx™). News release. August 11, 2025. Accessed August 11, 2025. https://www.pharmather.com/news/pharmather-announces-fda-approval-of-ketamine-ketarxtm

2. PhamaTher. KETARx™​. Accessed August 11, 2025. https://www.pharmather.com/ketarx-ketamine.html

3. PharmaTher. PharmaTher Provides Update on FDA New Drug Application for Ketamine. News release. February 12, 2025. Accessed August 6, 2025. https://www.pharmather.com/news/pharmather-provides-update-on-fda-new-drug-application-for-ketamine

4. Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia. ClinicalTrials.gov identifier: NCT04912115. Updated November 18, 2023. Accessed August 11, 2025. https://clinicaltrials.gov/study/NCT04912115

5. Parkinson’s News Today. Pharmather eyes commercialization of Parkinson’s ketamine treatment. July 8, 2025. Accessed August 11, 2025. https://parkinsonsnewstoday.com/news/pharmather-eyes-commercialization-parkinsons-ketamine-drug/