Ketamine Specialty Company PharmaTher Holdings Ltd. PHRRF submitted Type B Package of meetings to the FDA to discuss the remaining requirements for the KETARX on-body pumping system and to submit the appropriate New Drug Application (NDA) under the 505(b)(2) path by the end of 2023.
With the FDA meeting scheduled for March 23, CEO Fabio Chianelli stated that the company is seeking near-term FDA clearance for the KETARX body pump system in general anesthesia and sedation for surgical procedures.
More specifically, the new system would be used to maintain anesthesia and as an adjunct to other anesthetics. PharmaTher is also investigating its use for sedation purposes during short-term diagnostic and surgical procedures that allow for subcutaneous administration.
Chianelli said, “If this strategy is successful, it would provide a strong foundation for efficient expansion to mental health, neurological, and pain disorders,” given the system’s ability to deliver either anesthetics or subanesthetics over a defined period of time.
PharmaTher’s proprietary ketamine on-body pump system results in a subcutaneous infusion of racemic ketamine. The company believes this delivery system offers several advantages over the commonly used intravenous (IV) administration, including reducing the need for skilled personnel for administration and reducing pain, irritation and risk of systemic infection associated with IV -Administration.
Photo: Benzinga Edit with photo by Spotmatik Ltd on Shutterstock and Wikimedia Commons.
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