PharmaTher Initiates Filing of Abbreviated New Drug Application for KETARX™ (racemic ketamine) to the FDA

PharmaTher Holdings Ltd. (OTCQB: PHRRF / CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has filed a Pre-Submission Facility Correspondence in advance of its Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”) to support expedited review of its priority ANDA. The filing of a Pre-Submission Facility Correspondence will help achieve approval early compared to the standard ANDA approval times. The Company anticipates KETARX™ approval from the FDA as early as Q1-2024 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.

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 disorders encompassing mental health, neurological and pain. 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™, such as 10 mg/ml, 50 mg/ml and 100 mg/ml, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.

PharmaTher Holdings Ltd. develops and commercializes specialty pharmaceuticals exhibiting growing adoption and permitting novel delivery methods to enhance patient outcomes. The Company’s lead product is KETARX™ (racemic ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications. The Company is commercializing PharmaPatch™ (microneedle patch) with its partners to deliver psychedelics and drugs to treat infectious diseases.