FDA Approval of KETARx Unlocks New Era of Ketamine Treatments for Pain Mental Health and Neurological Disorders

The FDA has approved the racemic ketamine product from PharmaTher Holdings, KETARx, for the treatment of post-surgical pain. PharmaTher described the approval as the result of years of development and said it remains committed to advancing ketamine-based therapies for mental health, neurological, and pain disorders. The company characterized the new indication as a notable commercial and clinical advancement in these therapeutic areas.

FDA Approves Ketarx After Review, Opening Door to Wider Ketamine Uses and Market Growth

Ketamine is the only psychedelic or psychedelic-adjacent therapy included in the World Health Organization’s Model List of Essential Medicines. Along with esketamine (Spravato; Janssen Pharmaceuticals), a nasal spray formulation of ketamine, the drug is expected to see increased global market growth following the recent FDA approval of Ketarx.

The approval also lays the groundwork for expanding ketamine’s use in additional therapeutic areas. Current development efforts target depression, certain neurological and movement disorders such as Parkinson disease and amyotrophic lateral sclerosis, and the management of rare or chronic pain conditions including complex regional pain syndrome.

The decision follows a resubmission of the new drug application for Ketarx. The FDA previously issued complete response letters on April 18, 2024, and October 22, 2024, identifying “minor” deficiencies and requesting updated information related to the drug substance, drug product, manufacturing, and microbiology.

The agency noted no concerns regarding the stability of Ketarx submission batches and did not require new preclinical or clinical studies. In October, the FDA asked the manufacturer to resubmit the application by the end of February 2025, leading to the recent approval.

Ongoing Ketamine Shortages and Research Efforts Drive Push for New Treatments and Delivery Methods

Ketamine has been listed on the FDA’s drug shortage list since February 2018, emphasizing the need for a stable and high-quality supply. This concern is compounded by an FDA risk alert issued on October 10, 2023, warning of potential risks associated with compounded ketamine products used to treat psychiatric disorders.

Efforts to expand research and ensure legal access to psychedelic therapies have placed particular emphasis on care for veterans. The Veterans Health Administration, the largest integrated healthcare system in the United States, currently approves and funds ketamine infusions for retired military personnel with depression, post-traumatic stress disorder, and chronic pain.

PharmaTher has also submitted investigational new drug applications for ketamine in neurological conditions such as Parkinson disease, as well as for novel delivery systems including an on-body wearable pump and microneedle patch. A phase 2 randomized, double-blind, active, placebo-controlled trial (NCT04912115) found that subanesthetic intravenous ketamine infusions reduced levodopa-induced dyskinesia in patients with Parkinson disease and were well tolerated. However, the trial was suspended before its planned completion date of March 30, 2024, and its future remains uncertain.

“With FDA approval for ketamine now in hand, we are closer to realizing our goal of becoming a global leader in ketamine-based pharmaceuticals. We remain steadfast in our mission to harness the pharmaceutical potential of ketamine for a range of mental health, neurological, and pain disorders,” stated Fabio Chianelli, founder, chairman, and CEO of PharmaTher.

Author

Denisse Sandoval