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PharmaTher Announces FDA Approval of Ketamine (KETARx™)
Globenewswire· 2025-08-11 13:26
Core Insights - The U.S. FDA has approved PharmaTher's ketamine product, KETARx™, for surgical pain management, marking a significant milestone for the company and positioning it within the psychedelic pharmaceutical sector [1][2][3] Company Overview - PharmaTher Holdings Ltd. aims to become a global leader in ketamine-based pharmaceuticals, focusing on mental health, neurological, and pain disorders [2][5] - The company has a strong commitment to developing ketamine for various therapeutic areas, including depression, Parkinson's disease, ALS, and chronic pain management [3] Market Potential - The global ketamine market is currently valued at $750 million and is projected to grow to $3.42 billion by 2034, reflecting a compound annual growth rate (CAGR) of 16.4% [2] - SPRAVATO® (esketamine), an FDA-approved treatment for depression, is on track for sales of $1.6 billion, with expectations of reaching $3 billion to $3.5 billion by 2027-2028, highlighting the market's potential for KETARx™ [2] Regulatory Context - The FDA's approval of KETARx™ provides a foundation for expanding ketamine's development across various therapeutic areas, addressing a significant need for a consistent, high-quality supply of ketamine [3][4] - The FDA has recognized the importance of expanding research and access to psychedelic therapies, particularly for veterans suffering from mental health issues [4]