PharmaTher and Vitruvias Therapeutics have entered a collaboration deal to commercialise PharmaTher’s Ketarx (racemic ketamine) in the US.

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications.

Ketamine is currently on the FDA’s drug shortage list.

It is being given in hospitals and clinics for the treatment of mental health, neurological and pain disorders outside the FDA-approved indications.

PharmaTher plans to file an abbreviated new drug application with the FDA for Ketarx in July 2023, and to secure approval in the first quarter of 2024. Ketarx will then be commercially launched in the second quarter.

The company and Vitruvias are planning pre-launch activities, including distribution, trade relations, pricing, marketing, and managed care and sales plans.

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PharmaTher CEO Fabio Chianelli stated: “Our highest priority is to obtain regulatory approvals and to commercialise Ketarx (racemic ketamine) worldwide for unmet medical needs.

“We are focused on building a network of strong commercial partnerships with leading speciality generic companies that are experienced in 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 US market and believe Vitruvias is the ideal partner to rapidly progress our commercialisation goals in the US and unlock new commercial opportunities internationally.”

This partnership with Vitruvias prepares the way for a definitive agreement under which PharmaTher will handle the regulation, production and supply of Ketarx.

Vitruvias would then undertake distribution, marketing and sales of Ketarx to hospital, institutional and clinic channels in the country.