FDA approves epinephrine nasal spray for anaphylaxis

Key takeaways:

• The approval is based on four studies in which neffy provided comparable epinephrine delivery to current alternatives.
• Treatment with neffy also offered similar epinephrine concentrations in children and adults.

The FDA has approved neffy epinephrine nasal spray for emergency treatment of Type 1 allergic reactions, including anaphylaxis, in pediatric and adult individuals weighing at least 66 pounds.

According to an FDA release, approval of single-dose neffy (ARS Pharmaceuticals) was based on four studies which analyzed epinephrine concentrations in the blood of 175 healthy adults following delivery of the spray or other approved epinephrine injection treatments.

Data showed that neffy offered epinephrine concentrations comparable with currently available alternatives.

“We commend the FDA's decision to approve neffy, which offers the food allergy community a nasal-spray epinephrine delivery device,” Sung Poblete, PhD, RN, CEO of Food Allergy Research and Education, told Healio in an email. “This needle-free breakthrough should make it easier for food allergy patients and those around them to administer epinephrine in the event of an anaphylactic reaction.”

Neffy also showed similar increases in heart rate and blood pressure vs. epinephrine injection products. A previous analysis of neffy in child patients weighing more than 66 pounds demonstrated epinephrine concentrations in children comparable to adults who received the nasal spray.

“This approval marks a watershed moment in addressing an unmet medical need for people with Type 1 allergies,” Richard Lowenthal, co-founder, president and CEO of ARS Pharmaceuticals, said in a company press release. “We thank the FDA staff for their partnership and support and are deeply grateful to the severe allergy community, including advocates, patients, parents and health care professionals, for their contributions to the development of neffy as an important, life-saving treatment.”

As Healio previously reported, ARS Pharma submitted a complete response letter to the FDA in April of this year following a request from the FDA to study pharmacokinetic and pharmacodynamic effects of repeat doses in patients experiencing nasal allergen challenge conditions. Neffy was recommended for approval in the European Union in July.

References:

• ARS Pharmaceuticals receives FDA approval of neffy (epinepherine nasal spray), the first and only needle-free treatment for type 1 allergic reactions, including anaphylaxis. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine. Published Aug. 9, 2024. Accessed Aug. 9, 2024.
• FDA approves first nasal spray for treatment of anaphylaxis. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis. Published Aug. 9, 2024. Accessed Aug. 9, 2024.