Health and Healthcare

How Insys Is Winning With This FDA Update

Chris Lange

Published: August 30, 2018 9:45 am

Last Updated: January 11, 2020 6:36 pm

Insys Therapeutics Inc. (NASDAQ: INSY) shares made a handy gain early on Thursday after the company announced an update from the U.S. Food and Drug Administration (FDA).

Specifically, the FDA granted a Fast Track designation to the company’s epinephrine nasal spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.

In a previous clinical trial, the intranasal epinephrine product showed promise as a potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection for the treatment of anaphylaxis. Preliminary results demonstrated rapid drug absorption with the epinephrine nasal spray and showed that the intranasal delivery was similar to that of intramuscular injection with EpiPen.

According to the Mayo Clinic, more than 200,000 cases of anaphylaxis occur each year in the United States. The World Allergy Organization estimates that up to 2% of the global population — as many as 150 million people worldwide — will experience anaphylaxis during their lifetime.

Steve Sherman, senior vice president of regulatory affairs for Insys Therapeutics, commented:

The receipt of Fast Track designation represents a significant milestone for INSYS and our clinical development of this novel drug-device combination. 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.

Shares of Insys traded after Thursday’s opening bell at $8.75, or up about 10%. The consensus analyst price target is $9.60, and the 52-week trading range is $4.10 to $14.00.