Insys Therapeutics said that preliminary data from a Phase 1 pharmacokinetics study comparing its intranasal epinephrine formulation to EpiPen intramuscular epinephrine in 60 subjects with seasonal allergies showed similar bioavailability and rapid drug absorption for the nasal spray. The company did not provide any details.
Advisory board member David Fleischer of the University of Colorado School of Medicine said, “If the results of the initial study are borne out in a subsequent trial, this epinephrine nasal spray may become a viable alternative for patients with food allergy, venom allergy or other causes of anaphylaxis who must be prepared to treat it rapidly and effectively when it occurs. Because epinephrine is the first-line treatment for anaphylaxis, having other effective delivery options, such as a needleless alternative, may be attractive to patients and healthcare providers, as well as parents, school nurses, first responders and emergency department staff.”
Insys Therapeutics President and CEO Saeed Motahari, commented, “This is an exciting milestone for people affected by severe allergies who might be seeking an alternative delivery mechanism for epinephrine. Given that epinephrine is on the FDA shortage list, we look forward to working closely with the agency to determine the optimal path to making this investigational novel drug delivery system available to those in need.”
Read the Insys Therapeutics press release.
