Improving DxMultiomics, Powered by Your Choices

We're building DxMultiomics to be The Central Nexus of Biotech Intelligence. To ensure a seamless experience and continuous improvement, we utilize website analytics. These tools help us monitor site performance, understand how users navigate the platform, and identify opportunities to make your research journey more efficient. We handle this data with the utmost respect for your privacy, and you can choose what works best for you.

PharmaTher Announces FDA Approval of KETARx™ for use in surgical pain management
_↗ pharmather.com
News Image

PharmaTher Holdings Ltd. announced that its ketamine product, KETARx™, received U.S. Food and Drug Administration (FDA) approval on August 8, 2025. This approval is specifically for its indicated uses in surgical pain management. The announcement marks a significant milestone for PharmaTher, strategically positioning the company within the rapidly evolving psychedelic pharmaceutical industry.

According to Fabio Chianelli, Founder, Chairman and CEO of PharmaTher, this FDA approval represents a "new chapter" for the company and is a testament to its dedicated development efforts. The approval is expected to serve as a catalyst for PharmaTher's growth, enabling it to pursue its goal of becoming a global leader in ketamine-based pharmaceuticals. The broader market for ketamine and psychedelic-adjacent drugs is experiencing substantial growth. The global ketamine market is currently valued at $750 million and is projected to reach $3.42 billion by 2034, with a compound annual growth rate of 16.4%. This growth is further underscored by the commercial success of other approved treatments, such as SPRAVATO® (esketamine), which is an FDA-approved treatment for depression with a current sales run rate of $1.6 billion. Ketamine itself holds a unique position, being the only psychedelic or psychedelic-adjacent drug included on the World Health Organization's Model List of Essential Medicines.

The FDA's approval of KETARx™ for surgical pain management provides a strong foundation for PharmaTher to expand the development of ketamine across a diverse range of therapeutic areas. The company's product pipeline includes initiatives targeting Mental Health: Conditions such as depression, Neurological Disorders: Including Parkinson's disease and Amyotrophic Lateral Sclerosis (ALS) and Pain Disorders: Rare or chronic pain conditions, such as Complex Regional Pain Syndrome (CRPS).

The approval of KETARx™ helps to address a significant unmet need in the healthcare system. Since February 2018, ketamine has been on the FDA drug shortage list, highlighting a critical need for a consistent and reliable supply. Furthermore, the FDA issued a compounding risk alert in October 2023, detailing potential risks associated with compounded ketamine products used for psychiatric disorders. The availability of an FDA-approved, high-quality product like KETARx™ mitigates these concerns.



Log In
Sign Up