INSYS Therapeutics announced Thursday that it has begun a proof-of-concept study of two formulations of epinephrine nasal spray for the treatment of anaphylaxis with the enrollment of the first patient.
This Phase I clinical trial is designed to establish whether intranasal administration of epinephrine is bioequivalent to the standard method of delivering the drug via intramuscular injection.
“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,” said Steve Sherman, senior vice president of regulatory affairs at INSYS Therapeutics. “This study will test that hypothesis.”
The study will enroll a total of 60 adult patients 18–45 years of age in five 12-patient cohorts at a single clinical site. To qualify for enrollment, all study patients will be confirmed to be healthy subjects with a history of seasonal allergies; after enrollment, they will be exposed to an intranasal allergen at specific time points as part of the protocol.
The study has three primary objectives: first, to compare the bioavailability of aqueous formulations to that of hydro-alcoholic formulations of the company’s proprietary epinephrine nasal spray at two doses (3mg and 6mg); second, to compare the bioavailability of both formulations (aqueous and hydro-alcoholic) to that of the standard intramuscular injection — specifically, EpiPen® (0.30mg); and third, to evaluate the effect of an intranasal allergen challenge on the bioavailability of both intranasal epinephrine spray formulations at both doses. Secondarily, the study will evaluate the safety and tolerability of both formulations at both doses.
INSYS expects enrollment in the study to be complete in the first quarter of 2018, with initial results for all enrolled patients available by February. Based on the results, the company will decide whether to proceed with additional trial phases as part of its clinical development program.