Neffy, FDA-approved alternative nasal spray to EpiPen for allergic reactions

The US Food and Drug Administration has approved ARS Pharmaceuticals’ nasal spray as the first emergency needle-free treatment for potentially fatal allergic reactions.

The spray, which will be sold under the brand name neffy, is seen as an alternative to the EpiPen and other auto-injectors that are filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.

Neffy is expected to be available in the United States within eight weeks of FDA approval, the company said.

ARS Pharma will offer neffy at a price of $199 for two doses through digital pharmacy sites such as BlinkRx and GoodRx to eligible patients whose insurance plans do not cover Neffy.

Some commercially insured patients can access the treatment for $25 per prescription filled for two single-use neffy devices through a co-pay savings program.

Anaphylaxis is a severe, life-threatening allergic reaction that usually involves multiple parts of the body and is considered a medical emergency.

Neffy, a single-dose nasal spray administered into one nostril, is approved for use in adult and pediatric patients weighing at least 30 kilograms.

“Some people, especially children, may delay or avoid treatment because of fear of injections,” said Kelly Stone, an associate director at the FDA’s Center for Drug Evaluation and Research, adding that the availability of the nasal spray could reduce barriers to prompt treatment. .

Last year, the US health regulator refused to approve the spray and requested additional testing, in a decision that contradicted the recommendation of its independent experts.

Lianne Mandelbaum, a parent of a child with food allergies whom Reuters contacted through ARS Pharma, said the decision was long overdue and has “the potential to be a game changer for the community”.

“I don’t see doing a complete switch yet,” she said, adding that she will continue to keep the auto injectors as well as Neffy.

ARS shares rose over 13% to $11.22 on the FDA approval.