Psychedelic biotech company PharmaTher is advancing on plans to bring to the market a next-generation treatment for mental health, neurological, and pain disorders, with a new delivery system for ketamine and other psychedelic medicines.
The company this week announced it filed a pre-Investigational New Drug (IND) meeting request and complete IND briefing package with the U.S. Food and Drug Administration (FDA) to support the clinical development of Ketabet, a hydrogel-forming microneedle patch. PharmaTher wants to discuss with the agency a proposed Phase 2 clinical study for major depressive disorder as well as the product development plan for its patented hydrogel-forming microneedle patch delivery technology for ketamine and other psychedelic medicines.
PharmaTher says its novel delivery system holds the potential to reduce side effects and allow for an optimized and continuous medicine delivery in a way that oral, inhaled, injectable, or intravenous psychedelics cannot. The company believes the patch has the potential to receive FDA approval under the agency’s fast track designation. The designation is designed to expedite the review of drugs that treat serious conditions in order to get much-needed medications to patients earlier.
“We have an insatiable focus on developing and commercializing novel uses, formulations, and delivery forms of ketamine,” says Fabio Chianelli, Chief Executive Officer of PharmaTher. “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.”
