SOURCE: INSYS Therapeutics

Insys Therapeutics

August 17, 2015 12:22 ET

Insys Therapeutics' Dronabinol Oral Solution NDA Accepted for Filing by FDA

April 1, 2016 PDUFA Approval Expected

PHOENIX, AZ--(Marketwired - Aug 17, 2015) - Insys Therapeutics, Inc. ("Insys" or "the Company") (NASDAQ: INSY) today announced that the New Drug Application (NDA) for its proprietary Dronabinol Oral Solution has been accepted for filing by the U.S. Food and Drug Administration ("FDA"). The Prescription Drug User Fee Act ("PDUFA") goal date for a decision on this NDA is April 1, 2016, which reflects a Standard Review by the FDA.

"We are very pleased to have our NDA for Dronabinol Oral Solution filing accepted by the FDA. We believe Dronabinol Oral Solution can become an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with AIDS. We will continue to work closely with the FDA throughout the review process for the approval of this significant product," said Michael Babich, President and Chief Executive Officer. 

The Dronabinol Oral Solution NDA requests FDA approval 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").

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 proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. The Company recently submitted a New Drug Application to the U.S. Food and Drug Administration for Dronabinol Oral Solution, a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule. Insys 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 including related to our belief that our Dronabinol Oral Solution formulation can become an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with AIDS and has distinct advantages over the current formulation of dronabinol in soft gel capsule. 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 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.