FDA Approves PharmaTher’s Ketamine for Surgical Pain Management

On August 8, 2025, the US Food and Drug Administration (FDA) approved PharmaTher’s ketamine (KetaRx) for 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,” said PharmaTher Founder and CEO Fabio Chianelli in a statement.1

This decision follows 2 complete response letters (CRLs) issued on October 22, 2024, and April 18, 2024, citing deficiencies in the Abbreviated New Drug Application (NDA) for ketamine for anesthesia, sedation, pain, mental health, and neurological indications.2 The deficiencies were classified as minor, and the FDA requested clarification on drug substance, drug product, manufacturing, and microbiology. The Agency did not request new trials, nor did they express concern about the stability of ketamine submission batches, which have demonstrated stability for 18 months.

Ketamine, a dissociative anesthetic hallucinogen, is the only psychedelic included on the World Health Organization’s Model List of Essential Medicines.3 This drug works by blocking NDMA brain receptors, increasing serotonin and other mood-improving neurotransmitters. Many trials have examined ketamine for depression, and the FDA approved esketamine (Spravato), the derivative of ketamine, in 2019.4

Ketamine has repeatedly sat on the FDA shortage drug list since February 2018. With the scarcity of ketamine, many have prescribed compounded ketamine products for psychiatric disorders and pain despite potential risks, including abuse and misuse, psychiatric events, increases in blood pressure, respiratory depression, and lower urinary tract and bladder symptoms.5

Ketamine is expected to grow from $750 million today to $3.42 billion by 2035, with a compound annual growth rate of 16.4%. For esketamine, sales are projected to rise from $1.6 billion to $3 or $3.5 billion in 2027 – 2028.1

The company stated that this approval lays a strong foundation for advancing ketamine development in other areas, including psychiatric disorders like depression, neurological disorders such as Parkinson Disease and Amyotrophic Lateral Sclerosis, and rare or chronic pain like Complex Regional Pain Syndrome.

“This historic FDA approval for PharmaTher is a testament to years of dedicated development, signaling a new era of growth,” Chianelli said. “We remain steadfast in our mission to harness the pharmaceutical potential of ketamine for a range of mental health, neurological, and pain disorders.”

References

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

2. Derman, C. FDA Issues CRL for Ketamine to Treat Pain, Mental Health, and More. HCPLive. October 23, 2024. Accessed August 11, 2025. https://www.hcplive.com/view/fda-issues-crl-ketamine-treat-pain-mental-health-more.

3. Ketamine. United States Drug Enforcement Administration. https://www.dea.gov/factsheets/ketamine. Accessed August 11, 2025

4. The Difference Between Ketamine and Esketamine. BestMind Behaviorial Health.September 2, 2024. https://bestmindbh.com/blog/difference-between-ketamine-and-esketamine/. Accessed August 11, 2025.

5. FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders. US Food and Drug Administration. October 10, 2023. Accessed August 11, 2025. https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine.