The U.S. Food and Drug Administration has approved a nasal spray from ARS Pharmaceuticals as the first needle-free emergency treatment for a potentially deadly allergic reaction.
The spray, sold under the brand name Nephi, is seen as an alternative to EpiPens and other auto-injectors filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.
The company said Nefi is expected to be available in the U.S. within eight weeks of FDA approval.
ARS Pharma will offer two doses of Nephi for $199 through digital pharmacy sites such as BlinkRx and GoodRx to eligible patients whose insurance plans don’t cover the drug.
Some patients with private insurance can get treatment for $25 per prescription for two disposable Nephi devices through a copay savings program.
Anaphylaxis is a severe, life-threatening allergic reaction that usually affects multiple parts of the body and is considered a medical emergency.
Nefi is a single-dose nasal spray administered into one nostril and is approved for use in adult and pediatric patients weighing 30 kilograms or more.
“Some people may delay or avoid treatment because they’re afraid of injections,” said Kelly Stone, deputy director of the FDA’s Center for Drug Evaluation and Research, adding that the availability of a nasal spray could reduce a barrier to speedy treatment.
Last year, U.S. health officials refused to approve the spray and called for further testing, a decision that went against the recommendations of their own independent experts.
Lianne Mandelbaum, a parent of a child with food allergies contacted by Reuters through ARS Pharma, said the decision was long overdue and “could mean a big change for the community.”
“We’re not ready to switch completely yet,” she said, adding that she will continue to carry autoinjectors as well as Nephi.
Following the FDA approval, ARS shares rose more than 13% to $11.22.
