PharmaTher Holdings Ltd. announced it has entered into a collaboration agreement with Vitruvias Therapeutics Inc, for the commercialization of the Companyâs KETARX⢠(racemic ketamine) products in the U.S. In partnership with Vitruvias, KETARX⢠will be marketed under ketamineâs 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 FDAâs 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 (âANDAâ) for KETARX⢠(racemic ketamine) with the FDA in early July and obtain FDA approval in first quarter 2024. In anticipation of a potential commercial launch of KETARX⢠in second quarter 2024, PharmaTher and Vitruvias will work together on pre-commercial launch activities, including marketing, pricing, distribution, managed care, trade relations and sales plans. The collaboration contemplates a definitive agreement whereby PharmaTher would be responsible for regulatory, manufacturing and supply of KETARXâ¢, and Vitruvias would be responsible for the marketing, sales, and distribution to hospitals, institutional and clinics channels in the U.S. market.