Insys Therapeutics reports results of PK study for epinephrine nasal spray
INSYS Therapeutics announced the results of a dose-finding pharmacokinetic study of its epinephrine nasal spray. These results identified a dose that showed a PK profile similar to that of intramuscular injection of EpiPen and Adrenalin, both of which are treatments for anaphylaxis, an acute, life-threatening allergic reaction. 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 and Adrenalin in 49 healthy volunteers. Additionally, as reported on Jun. 14, 2018, the proof-of-concept PK study, demonstrated rapid drug absorption through the nasal mucosa and similar bioavailability to that of an intramuscular injection of EpiPen in nasal allergen challenged subjects.