PharmaTher Holdings Ltd., a Canada-based specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, has received approval from the US Food and Drug Administration (FDA) for its ketamine product, KETARx, for use in surgical pain management. 

Fabio Chianelli, Founder, Chairman and CEO of PharmaTher, described this achievement as a “new chapter” for the company.  

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

Ketamine is unique among psychedelic and psychedelic-adjacent drugs as it is the only one included on the World Health Organization (WHO)'s Model List of Essential Medicines. The global ketamine market is poised for significant growth, with its current valuation of USD 750 million projected to rise to USD 3.42 billion by 2034, reflecting a compound annual growth rate (CAGR) of 16.4 percent.

Additionally, SPRAVATO (esketamine), an FDA-approved treatment for depression, is on track to achieve an annual sales run rate of USD 1.6 billion, with projections ranging between USD 3 billion and USD 3.5 billion by 2027–2028.

This promising market outlook underscores the potential of KETARx and PharmaTher’s strategic position in the industry.

The FDA's approval of KETARx provides a strong foundation for expanding the development of ketamine across diverse therapeutic areas within the company's product pipeline. These areas include mental health conditions like depression, neurological disorders such as Parkinson's disease and Amyotrophic Lateral Sclerosis (ALS), and the management of rare or chronic pain, including Complex Regional Pain Syndrome (CRPS).

Since February 2018, ketamine has been regularly listed on the FDA drug shortage list, highlighting a significant need for a consistent, high-quality supply. This issue is cautioned by a compounding risk alert issued by the FDA on October 10, 20234, which detailed potential risks associated with compounded ketamine products used for psychiatric disorders.  

Robert F. Kennedy Jr., Secretary of Health and Human Services, has also emphasized the importance of expanding research and ensuring legal access to psychedelic therapies for veterans. The Veterans Health Administration, the largest integrated healthcare system in the US, currently approves and funds ketamine infusions for retired military personnel afflicted with depression, PTSD, and chronic pain.

Furthermore, FDA Commissioner Marty Makary's establishment of the Commissioner's National Priority Voucher program signifies the FDA's dedication to expediting access to safe and effective treatments, instilling confidence in potential future regulatory support and accessibility for ketamine.