INSYS Therapeutics announced preliminary results from an early study showing that their proprietary formulation of epinephrine delivered intranasally had similar bioavailability to an intramuscular injection of EpiPen (0.3mg; Mylan).
The pharmacokinetics trial, which included 60 participants with seasonal allergies, also demonstrated rapid drug absorption with the intranasal spray.
“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,” said Dr David Fleischer of the University of Colorado School of Medicine and Children’s Hospital Colorado who served as an advisory board physician.
Commenting on the next steps for development, president and CEO of INSYS, Saeed Motahari said “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.”
Epinephrine acts on both alpha- and beta-adrenergic receptors. Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension. Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis.
For more information visit Insysrx.com.