Insys Therapeutics has secured a fast track designation from the US Food and Drug Administration (FDA) for its epinephrine nasal spray as an investigational treatment for anaphylaxis.


Image: FDA Building in Silver Spring, Maryland. Photo: Courtesy of the US Food and Drug Administration/

The company said in an earlier clinical trial, the intranasal epinephrine product candidate demonstrated promising results, as a potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection for treating anaphylaxis.

The study involved 60 people with seasonal allergies and the preliminary results showed rapid drug absorption with epinephrine nasal spray.

The bioavailability of Insys’ new formulation of epinephrine, when delivered intranasally was similar to that of intramuscular injection with EpiPen (0.3 mg).

Anaphylaxis is an acute, life-threatening allergic reaction requiring urgent treatment.

As per Mayo Clinic, more than 200,000 cases of anaphylaxis occur each year in the US. The World Allergy Organization estimates that up to 2% of the world’s population or as many as 150 million people have chances of experiencing anaphylaxis during their lifetime.

Insys Therapeutics regulatory affairs senior vice president Steve Sherman said: “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.”

Last year, the company also received fast track designation for another of its product candidates, cannabidiol (CBD) oral solution as an investigational treatment for the genetic condition Prader-Willi syndrome.

The clinical development for the product is presently in Phase 2 with ongoing patient enrollment. The company’s formulation of pharmaceutical-grade CBD is also being evaluated for childhood absence epilepsy (phase 2) and infantile spasms (phase 3).

Insys Therapeutics is engaged in the development of products that can address unmet medical needs and clinical shortcomings of existing commercial products.

The company is committed in developing medications for potentially treating anaphylaxis, epilepsy, Prader-Willi syndrome, opioid addiction and overdose, and other diseases which are significantly unmet.