Insys Therapeutics Submits NDA for Dronabinol Oral Solution

Insys Therapeutics, Inc. INSY today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 (THC). "We are very pleased to have re-submitted the NDA Dronabinol Oral Solution, which was facilitated by our obtaining FDA agreement with the requisite pediatric study plan. We believe Dronabinol Oral Solution can become an important new option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with AIDS," said Michael L. Babich, President and Chief Executive Officer. Insys 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 (CBD), for its research needs and to meet anticipated demand for its pipeline products, if approved. The Company received a Refusal to File (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.