FDA grants fast track designation to Insys’ Naloxone Sublingual Spray

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.

Insys president and CEO Michael Babich said: "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."

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.