Posted by Michael Wonder on 03 Sep 2018
FDA grants Insys Therapeutics ‘fast track’ designation for epinephrine nasal spray as investigational treatment for anaphylaxis
30 August 2018 - Insys Therapeutics announced today that the U.S. 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.
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).
