Insys Submits NDA For Dronabinol Oral Solution - Quick Facts

(RTTNews) - Insys Therapeutics, Inc. (INSY) announced it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol or THC, Insys stated.

Insys said it expects that its new, DEA-inspected facility in Round Rock, Texas will enable it to manufacture ample quantities of its pharmaceutical-grade cannabinoid products, including Dronabinol Oral Solution and pharmaceutical cannabidiol or CBD, for its research needs and to meet anticipated demand for its pipeline products, if approved.

The company stated that it received a Refusal to File or RTF letter in October 2014 for its previously-submitted NDA for Dronabinol Oral Solution because that submission included an inadequate or incomplete pediatric study plan to conduct studies to assess the safety and effectiveness of Dronabinol Oral Solution in pediatric patients.

The company expects the current NDA contains all information required to permit a substantive review by the FDA, and intends to continue to work closely with the FDA throughout the review process.