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FDA fast tracks Epinephrine nasal spray for anaphylaxis

Insys Therapeutics  has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to their investigational Epinephrine Nasal Spray, a potential treatment for anaphylaxis.

In a clinical trial, the company say that preliminary data (n=60) of patients with seasonal allergies showed rapid absorption of intranasal epinephrine. The bioavailability of the novel epinephrine nasal spray also proved similar to that of intramuscular injection with EpiPen 0.3mg injection.

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. Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation that helps alleviate bronchospasm, wheezing and dyspnoea that may occur during anaphylaxis.

“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," stated Dr David Fleischer, an associate professor of paediatrics at the University of Colorado School of Medicine and Children's Hospital Colorado who served as an advisory board physician.

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