FDA Grants INSYS Therapeutics ‘Fast Track’ Designation for Epinephrine Nasal Spray as Investigational Treatment for Anaphylaxis

INSYS Therapeutics (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced that the U.S. Food and Drug Administration (FDA) has granted 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.

As quoted in the press release:

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

In a previous clinical trial, the intranasal epinephrine product candidate from INSYS showed promise as a potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection for the treatment of anaphylaxis. Preliminary results from this pharmacokinetic study involving 60 people with seasonal allergies demonstrated rapid drug absorption with the epinephrine nasal spray and showed that the bioavailability of the company’s novel, proprietary formulation of epinephrine delivered intranasally was similar to that of intramuscular injection with EpiPen^® (0.3 mg).

Click here to read the full press release.