Insys Therapeutics Skyrockets on FDA Fast Track Designation

Shares of Insys Therapeutics were on the rise in Thursday’s trading session after the company announced that its epinephrine nasal spray was given fast track designation from the Food & Drug Administration.

The FDA has given fast track designation to Insys Therapeutics’ epinephrine nasal spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.

The company, which develops, manufactures, and commercializes pharmaceutical cannabinoids and spray technology, said that the previous clinical trial, showed promise as a potential “needle-free, non-invasive and easy-to-use alternative” to intramuscular injection

“The receipt of Fast Track designation represents a significant milestone for Insys and our clinical development of this novel drug-device combination,” remarked Steve Sherman, senior vice president of regulatory affairs for the company.

He added, “We look forward to working with the agency to make it available to those who may be interested in an alternative to intramuscular auto-injectors as soon as possible.”

The Mayo Clinic has said that more than 200,000 cases of anaphylaxis occur each year in the United States while the World Allergy Organization estimates that up to two percent of the global population will experience anaphylaxis during their lifetime.

Disclaimer: We have no position in INSYS Therapeutics, Inc. (NASDAQ: INSY) and have not been compensated for this article.