Insys Therapeutics Intends To File NDA For Dronabinol Oral Solution In Q3

(RTTNews) - Insys Therapeutics Inc.(INSY) announced the successful completion of a human abuse study for Dronabinol Oral Solution, its proprietary, orally administered liquid formulation of the synthetic cannabinoid dronabinol in development for the treatment of chemotherapy induced nausea and vomiting or CINV and anorexia associated with weight loss in patients with AIDS.

Insys said it completed the clinical portion of the New Drug Application (NDA) for Dronabinol Oral Solution during the third quarter of 2013, as previously announced. The human abuse study was required by the U.S. Drug Enforcement Agency (DEA) for scheduling classification purposes. The company now intends to file this NDA in the third quarter of 2014.

Dronabinol is currently available only in a soft gelatin capsule form. According to Symphony Health Solutions, total prescriptions of Dronabinol grew 5% in 2013 as compared to 2012. While the capsule is available in only three strengths (2.5mg, 5 mg and 10 mg), Insys' Dronabinol Oral Solution presents an opportunity for physicians to titrate more effectively.