SOURCE: INSYS Therapeutics

Insys Therapeutics

October 29, 2015 15:03 ET

Insys Therapeutics Announces Its Naloxone Sublingual Spray Received Fast Track Designation From the FDA for the Treatment of Opioid Intoxication or Overdose

PHOENIX, AZ--(Marketwired - Oct 29, 2015) - Insys Therapeutics, Inc. (NASDAQ: INSY) ("Insys" or "the Company") today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to its Naloxone Sublingual Spray for the treatment of known or suspected opioid intoxication or overdose.

FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions and address an unmet medical need. A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval to get important new drugs to the patient earlier.

"We are encouraged by the Fast Track designation that will allow us to advance our program to address a significant unmet medical need in the market. Opioids are responsible for a high proportion of fatal drug overdoses around the world because of their capacity to cause respiratory depression. We believe the extension of our sublingual spray platform with our Naloxone molecule, if approved by the FDA, will offer patients a needle-free solution to treat known or suspected opioid intoxication or overdose. We welcome the opportunity the Fast Track designation affords us in advancing our sublingual spray pipeline to benefit patient care and build shareholder value," said Michael L. Babich, President and Chief Executive Officer of Insys.

Incidence of Opioid Overdoses

According to the Centers for Disease Control and Prevention (CDC), the total number of opioid overdoses increased consecutively from 1999 through 2010, outnumbering deaths from gunshot wounds or motor vehicle crashes. Approximately 60% of the more than 38,300 overdose deaths in 2010 involved pharmaceutical drugs. Three of every four pharmaceutical overdose deaths, or over 16,600, were due to opioid analgesics.

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. Insys currently markets two products: Subsys® (fentanyl sublingual spray), and a generic version of Dronabinol (THC) capsules. 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 statements regarding the development of Insys' pipeline of sublingual sprays, expected study and program outcomes related to the research and development efforts of the company and its pipeline and past or future meetings with governmental agencies including the FDA. 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.