PharmaTher Submits Priority Original Abbreviated New Drug Application for KETARX (Ketamine) to the FDA

TORONTO, Sept. 06, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has submitted a priority original Abbreviated New Drug Application (“ANDA”) for KETARX (racemic ketamine) to the Food and Drug Administration (“FDA”) for expedited review of its ANDA. The Company anticipates KETARX approval and commercial launch in the U.S. in Q2-2024, followed by the pursuit of international approvals to support the growing global demand for ketamine.

“The submission of the ANDA for ketamine is a significant milestone for PharmaTher that brings us one step closer to becoming a global leader in ketamine and a commercial-focused specialty pharmaceutical company offering drugs that are in short supply with growing adoption for on-label and clinical needs,” said Fabio Chianelli, CEO of PharmaTher. “Ketamine has been on the FDA’s drug shortage list for over 5 years and its potential for mental health, neurological, and pain disorders continues to gain momentum and validation through published clinical research and real-world use cases.”

Ketamine is an essential medicine used for anaesthesia and analgesia (pain relief) listed on the WHO Essential Medicines List. Ketamine has been on the FDA’s drug shortage list since February 2018. In Canada, ketamine has been classified as a Tier 3 drug shortage since February 2023, and Health Canada has approved ketamine for use as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, ketamine is also being administered in hospitals and clinics to treat various mental health, neurological and pain disorders. A recently published new peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation.

PharmaTher’s priority is to commercialize KETARX in the U.S. under ketamine’s FDA-approved label through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company. The Company expects to market various dosage forms of KETARX, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.