SOURCE: INSYS Therapeutics

Insys Therapeutics

June 02, 2015 07:00 ET

Insys Therapeutics Submits NDA for Dronabinol Oral Solution

PHOENIX, AZ--(Marketwired - Jun 2, 2015) - Insys Therapeutics, Inc. (NASDAQ: 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.

About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using our proprietary sublingual spray technology and our capability to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. Insys currently markets two products, Subsys®, which is sublingual Fentanyl spray for breakthrough cancer pain, and a generic version of Dronabinol (THC) capsules. The Company has submitted an NDA for Dronabinol Oral Solution, and is developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol.

Subsys® is a registered trademark of Insys Therapeutics, Inc.

Forward-Looking Statements
This press release contains forward-looking statements regarding our research and development and clinical efforts, including statements related to the pipeline of products we are developing; our timeline regarding Dronabinol Oral Solution and the NDA related thereto, including the adequacy of the information in our current NDA; our belief regarding the market opportunity for Dronabinol Oral Solution; our belief that our Dronabinol Oral Solution formulation offers an important new option for patients; our expectations regarding our ability to manufacture ample quantities of our cannabinoid products. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2014 and any subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release and we undertake no obligation to publicly update or revise these statements, except as may be required by law.