Insys Therapeutics said that a dose finding study of its epinephrine nasal spray that enrolled 49 healthy volunteers demonstrated that one of two doses of the nasal spray tested had a PK profile comparable to the PK profiles of EpiPen (0.3 mg) and Adrenalin (0.5 mg).
In June 2018, the company reported results from a proof of concept PK study that showed similar bioavailability and rapid drug absorption for the nasal spray compared to EpiPen in subjects with seasonal allergies. In August 2018, the FDA granted Fast Track designation to the epinephrine nasal spray for the treatment of anaphylaxis.
Insys Senior VP of Research and Development Venkat Goskonda commented, “The results of our proof-of-concept (INS015-17-112) and dose-finding (INS015-18-124) studies confirmed that INSYS’ novel, proprietary formulation of epinephrine delivered intranasally potentially offers a viable, attractive alternative and non-invasive delivery option to the currently marketed products. These results enable us to select an appropriate dose for advancing to the next stage of clinical development. We look forward to working with the FDA to bring a new treatment option for allergy sufferers who experience anaphylaxis.”
Read the Insys Therapeutics press release.
