Specialty ketamine company PharmaTher Holdings Ltd. (OTCQB:PHRRF) submitted its Type B meeting package to the FDA to discuss the remaining requirements for the KETARX on-body pump system and submit the corresponding New Drug Application (NDA) under the 505(b)(2) pathway by the end of 2023.
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With the FDA meeting set for March 23, CEO Fabio Chianelli explained that, in the short term, the company aims to obtain FDA approval for KETARX on-body pump system in general anesthesia and sedation for surgical procedures.
More specifically, the new system would be applied to the maintenance of anesthesia and as a supplement to other anesthetic agents. PharmaTher is also assessing its use for sedation purposes during short-term diagnostic and surgical procedures that allow for subcutaneous administration.
Chianelli said, "if successful, this strategy would create a strong foundation in efficiently expanding to mental health, neurological and pain disorders," as the system has the capability to provide either anesthetic or subanesthetic dosing over a defined period of time.
PharmaTher's proprietary ketamine on-body pump system translates to a subcutaneous infusion of racemic ketamine. The company believes this delivery system holds several advantages over commonly-used intravenous (IV) administration including the decreased requirement for skilled personnel for its administration, and reduction in pain and irritation as well as the risk of systemic infection associated with IV administration.
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