In a 60-person pharmacokinetics study, early data show that the company’s intranasal formulation of epinephrine boasted similar bioavailability to epinephrine delivered via Mylan‘s (NSDQ:MYL) EpiPen auto-injector.
“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, an associate professor of pediatrics at the University of Colorado School of Medicine who served as an advisory board physician.
“This is an exciting milestone for people affected by severe allergies who might be seeking an alternative delivery mechanism for epinephrine,” Insys president & CEO Saeed Motahari said in prepared remarks. “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.”
INSY shares were trading at $8.34 apiece in mid-morning activity today, up +2.7%.