Insys Therapeutics Inc reported positive data for its investigational epinephrine nasal spray designed to treat anaphylaxis. The product was granted Fast Track designation by the FDA in August 2018.
The results of its dose-finding pharmacokinetic (PK) study identified a dose that showed a PK profile similar to that of intramuscular injection of EpiPen (0.3 mg) and Adrenalin (0.5 mg), both of which are treatments for anaphylaxis.
The dose-finding PK study, INS015-18-124, was a single-dose, open-label, randomized, four-treatment, four-way crossover study to assess the pharmacokinetics of two doses of epinephrine nasal spray and two reference products, EpiPen (0.3 mg) and Adrenalin (0.5 mg) in 49 healthy volunteers.
Additionally, as reported in June 2018, the proof-of-concept PK study (INS015-17-112), demonstrated rapid drug absorption through the nasal mucosa and similar bioavailability to that of an intramuscular injection of EpiPen (0.3mg) in nasal allergen challenged subjects.
The results confirmed that the product “potentially offers a viable, attractive alternative and noninvasive delivery option to the currently marketed products,” said Dr. Venkat Goskonda, senior vice president of research and development at Insys Therapeutics. “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.”