The first emergency treatment for potentially fatal allergic reactions without the use of needles is ARS Pharmaceuticals' nasal spray, which the US Food and Drug Administration approved on Friday.
Following the release, ARS Pharmaceuticals' stock increased by over 9%.
The spray, which will be marketed under the name Neffy, is thought to be a viable substitute for the EpiPen and other autoinjectors that contain epinephrine, which is used by those who are susceptible to anaphylaxis and other allergic responses. Kaleo's Auvi-Q is one such autoinjector.
An allergic reaction that is severe enough to be fatal, anaphylaxis usually affects many body parts and is a medical emergency.
Neffy is a nasal spray that is intended to be used once in a nostril and is approved for use in both adult and pediatric patients weighing 30 kg or more.
Kelly Stone, an associate director of the FDA's Center for Drug Evaluation and Research, stated that "some people, particularly children, may delay or avoid treatment due to fear of injections." She also added that the nasal spray's availability may lower barriers to prompt treatment.
Neffy's clearance is based on four studies that examined the blood levels of adrenaline after administering Neffy or other approved epinephrine injection products to 175 healthy persons who did not experience anaphylaxis.
In spite of the advice of its independent experts, the US health agency last year refused to authorize the spray and instead asked for more testing.
(Input from various sources)
(Rehash/Priyanka Pandey/MSM)