PharmaTher Secures FDA Approval for KETARx™ (Ketamine) in Surgical Pain Management
PharmaTher Holdings Ltd. (“PharmaTher” or the “Company”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company dedicated to advancing the therapeutic potential of ketamine, proudly announces that the U.S. Food and Drug Administration (FDA) has approved its ketamine product, KETARx™, as of August 8, 2025. This approval marks a significant milestone for PharmaTher, enabling the Company to further its mission of revolutionizing psychedelic pharmaceuticals for mental health, neurological, and pain disorders.
A Historic Achievement for PharmaTher
Fabio Chianelli, Founder, Chairman, and CEO of PharmaTher, expressed his enthusiasm:
“Today is a transformative moment for PharmaTher. With FDA approval for KETARx™, we are one step closer to becoming a global leader in ketamine-based pharmaceuticals. This achievement reflects years of dedicated research and development, paving the way for a new era of growth. We remain committed to unlocking the full pharmaceutical potential of ketamine to address a wide range of mental health, neurological, and pain conditions.”
Ketamine’s Growing Market Potential
Ketamine, recognized by the World Health Organization as an essential medicine, is uniquely positioned among psychedelic and psychedelic-adjacent drugs. The global ketamine market, currently valued at $750 million, is projected to grow to $3.42 billion by 2034, with a compound annual growth rate of 16.4%. Additionally, SPRAVATO® (esketamine), an FDA-approved treatment for depression, is on track to achieve annual sales of $3 billion to $3.5 billion by 2027-2028. This robust market outlook highlights the immense potential of KETARx™ and PharmaTher’s strategic positioning in the industry.
Expanding Therapeutic Applications
The FDA approval of KETARx™ provides a strong foundation for PharmaTher to expand its ketamine-based product pipeline. The Company is exploring applications in mental health conditions such as depression, neurological disorders including Parkinson’s disease and Amyotrophic Lateral Sclerosis (ALS), and chronic pain management, including Complex Regional Pain Syndrome (CRPS).
Addressing a Critical Need
Since February 2018, ketamine has been consistently listed on the FDA’s drug shortage list, underscoring the urgent need for a reliable, high-quality supply. This issue was further highlighted in an FDA compounding risk alert issued on October 10, 2023, which cautioned against the risks of compounded ketamine products for psychiatric use. Additionally, Robert F. Kennedy Jr., Secretary of Health and Human Services, has emphasized the importance of expanding research and ensuring legal access to psychedelic therapies, particularly for veterans. The Veterans Health Administration, the largest integrated healthcare system in the U.S., currently funds ketamine infusions for veterans suffering from depression, PTSD, and chronic pain. The FDA’s commitment to expediting access to safe and effective treatments, as demonstrated by initiatives like the Commissioner’s National Priority Voucher program, further supports the potential for ketamine’s broader therapeutic adoption.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty pharmaceutical company focused on harnessing the therapeutic potential of ketamine (KETARx™) for mental health, neurological, and pain disorders. For more information, visit PharmaTher.com.
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