Insys Therapeutics has announced the initiation of a Phase 1 proof-of-concept study to determine whether an epinephrine nasal spray for the treatment of anaphylaxis is bioequivalent to intramuscular injection of epinephrine. The trial will compare both aqueous and hydro-alcoholic formulations of intranasal epinephrine to EpiPen.
The study, which is expected to enroll 60 patients with a history of seasonal allergies, will also compare the bioavailability of each formulation at 3 and 6 mg doses to each other and will compare bioavailability of both formulations at both doses during an intranasal allergen challenge.
Insys Senior VP of Regulatory Affairs Steve Sherman said, “We believe that delivering epinephrine through the mucosa of the nasal passages has the potential to compare favorably to intramuscular injection, both clinically and practically. This study will test that hypothesis.”
The company said that it expects initial results of the study to be available by February 2018.
Read the Insys Therapeutics press release.
