FDA Approves KETARx for Management of Surgical Pain

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The US Food and Drug Administration (FDA) has approved PharmaTher Holdings’ ketamine product, KETARx, for its indicated uses in surgical pain management.¹

“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, signalling a new era of growth,” said Fabio Chianelli, founder, chairman, and CEO of PharmaTher.¹

This approval follows 2 complete response letters (CRLs), the first issued on October 22, 2024, and the second on April 18, 2024. The CRLs cited minor deficiencies in the Abbreviated New Drug Application for ketamine for anesthesia, sedation, pain, mental health, and neurological indications, and the FDA requested further clarification on drug substance, drug product, manufacturing, and microbiology. However, the FDA did not request new trials or express concern about the stability of ketamine submission batches, which have demonstrated stability for 18 months.²

PharmaTher believes this approval provides a strong foundation for the expansion of ketamine’s development across varied therapeutic areas, including in mental health conditions like depression, neurological disorders such as Parkinson disease and amyotrophic lateral sclerosis, and the management of rare or chronic pain, such as complex regional pain syndrome.

Despite rigid regulations and fears regarding its abuse, ketamine continues to show promise in treating a broad range of mental health conditions such as depression, schizophrenia, substance use disorder, posttraumatic stress disorder, and suicidal ideation.^3,4 Notably, several other ketamine products are making their way through the pipeline, including NRX-100, a preservative-free intravenous ketamine for the treatment of suicidal ideation in patients with depression, including bipolar depression.⁵ However, ketamine has been in short supply and is regularly listed on the FDA drug shortage list as of February 2018.¹

Approval in ketamine in relation to pain is a critical step for psychiatric care. While ketamine has been primarily investigated/approved in relation to treatment-resistant depression, individuals living with chronic pain are at heightened risk for mental health problems, including depression, anxiety, and substance use disorders. Additionally, chronic pain can affect sleep and increase stress levels. Overall, an estimated 35% to 45% of individuals with chronic pain experience depression.^6,7 Targeting pain could therefore enhance not only mental health outcomes, but overall quality of life for patients.

“We remain steadfast in our mission to harness the pharmaceutical potential of ketamine for a range of mental health, neurological, and pain disorders,” concluded Chianelli.¹

References

1. PharmaTher announces FDA approval of ketamine (KETARx™). News release. August 11, 2025. Accessed August 12, 2025. https://www.globenewswire.com/news-release/2025/08/11/3130994/0/en/PharmaTher-Announces-FDA-Approval-of-Ketamine-KETARx.html

2. PharmaTher provides update on FDA new drug application for ketamine. News release. February 12, 2025. Accessed August 12, 2025. https://www.pharmather.com/news/pharmather-provides-update-on-fda-new-drug-application-for-ketamine

3. Grunebaum MF, Galfalvy HC, Choo TH, et al. Ketamine for rapid reduction of suicidal thoughts in major depression: a midazolam-controlled randomized clinical trial. Am J Psychiatry. 2018;175(4):327-335.

4. Byock I. Taking psychedelics seriously. J Palliat Med. 2018;21(4):417-421.

5. Kuntz L. FDA fast track designation for NRX-100 for suicidal ideation in patients with depression, including bipolar depression. Psychiatric Times. August 11, 2025. https://www.psychiatrictimes.com/view/fda-fast-track-designation-for-nrx-100-for-suicidal-ideation-in-patients-with-depression-including-bipolar-depression

6. Chronic pain and mental health often interconnected. American Psychiatric Association. November 13, 2020. Accessed August 12, 2025. https://www.psychiatry.org/news-room/apa-blogs/chronic-pain-and-mental-health-interconnected

7. Vadivelu N, Kai AM, Kodumundi G, et al. Pain and psychology-a reciprocal relationship. Ochsner J. 2017;17(2):173-180.