PharmaTher, Vitruvias enter collaboration agreement for KETARX in the U.S.

PharmaTher announces it has entered into a collaboration agreement with Vitruvias Therapeutics for the commercialization of the Company’s KETARX products in the U.S. In partnership with Vitruvias, KETARX will be marketed under ketamine’s FDA-approved label and in various dosage forms, 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. market. Ketamine is currently on the FDA’s drug shortage list. Outside of the FDA approved indications, ketamine is also being administered in hospitals and clinics to treat various disorders encompassing mental health, neurological and pain. PharmaTher expects to file its abbreviated new drug application for KETARX with the FDA in early July and obtain FDA approval in Q1-2024. Fabio Chianelli, CEO of PharmaTher, commented: “Our highest priority is to obtain regulatory approvals and commercialize KETARX worldwide for unmet medical needs. We are focused on building a network of strong commercial partnerships with leading specialty generic companies that are experienced in the marketing, sales and distribution to the hospital, institutional and clinic channels within their territories. We are pleased to partner with Vitruvias for KETARX for the U.S. market and believe Vitruvias is the ideal partner to rapidly progress our commercialization goals in the U.S. and unlock new commercial opportunities internationally.”