PharmaTher Files FDA Pre-IND Meeting Request and Briefing Package For KETABET™ To Treat Depression

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has filed a pre-Investigational New Drug (“pre-IND”) meeting request and complete pre-IND briefing package with the U.S. Food and Drug Administration (“FDA”) to support the clinical development of KETABET™ and the proposed Phase 2 clinical study as a potential next-generation treatment for depression, and to discuss the product development plan for the Company’s patented hydrogel-forming microneedle patch delivery technology.

KETABET™ has the potential to receive FDA approval under the 505(b)(2) regulatory pathway and Fast Track designation by the FDA for treatment in patients with major depressive disorder. The hydrogel-forming microneedle patch offers a novel way to deliver ketamine and other psychedelics such as psilocybin, DMT, MDMA and LSD, and has the potential to improve on the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these psychedelics that currently must be taken orally, inhaled, injected and intravenously.

Fabio Chianelli, Chief Executive Officer of PharmaTher, commented: “We have an insatiable focus on developing and commercializing novel uses, formulations and delivery forms of ketamine. We are committed to solving the ketamine puzzle and unlocking its true potential to treat depression by leveraging our robust intellectual property portfolio, clinical and regulatory experience, and our recently approved IND by the FDA to evaluate ketamine to treat Parkinson’s disease in a Phase 2 study. We are now in a position to lead the way in reviving ketamine and KETABET™ as a potential FDA-approved prescription-based therapy for mental health, neurological and pain disorders.”

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