Insys submits Dronabinol oral solution New Drug Application

Supportive care specialist Insys Therapeutics has made a New Drug Application submission to the US Food and Drug Administration for its Dronabinol Oral Solution, a new medical marijuana therapy.

It is a new orally-administered liquid formulation of dronabinol (THC), a synthetic cannabinoid, developed for the treatment of chemotherapy-induced nausea and vomiting, and anorexia associated with weight loss in AIDS patients. The liquid formulation could offer advantages over dronabinol capsules, including a faster rate of absorption, more consistent blood levels and the ability to titrate to effect, the company noted.

Phase III trials with the product indicated bioequivalence by using 4.25mg of oral soluion versus 5mg of Marinol, which suggests patients may achieve similar clinical benefits with a lower dose of THC, and less intra-patient variability by over 60% when measuring total patient exposure to THC in the Dronabinol arm compared to Marinol.