Approval includes the treatment of anaphylaxis, with the indication covering adults and children who weigh ≥30 kg (66 lbs.). It marks a major innovation in epinephrine delivery as the first and only needle-free treatment option for people with severe allergic reactions. neffy could provide an alternative to the popular EpiPen option that utilizes a needle.
The single-dose nasal spray goes into one nostril. Users may take a second dose, using a new nasal spray in the same nostril, if they have no improvement in symptoms or they worsen.
ARS Pharmaceutical developed neffy with the Neurelis Intravail transmucosal absorption enhancement technology. Intravail enhances drug absorption through the nasal mucosa. This enables the noninvasive delivery of protein, peptide and small-molecule drugs.
The FDA in December 2022 accepted a new drug application (NDA) for neffy. However, last fall, the FDA asked for more information before it could approve the nasal spray.
“This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies – a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” said Richard Lowenthal, co-Founder, President and CEO, ARS Pharmaceuticals. “Epinephrine treatment is only effective if available, readily usable, and administered appropriately. Our team has worked tirelessly to create an easy-to-carry, easy-to-use, needle-free device that offers peace of mind to patients and caregivers by enabling them to administer epinephrine quickly and confidently when needed.
“We thank the FDA staff for their partnership and support in the development of neffy, and are deeply grateful to the severe allergy community, including advocates, patients, parents, and healthcare professionals, for their contributions to the development of neffy as an important, life-saving treatment.”
How ARS Pharmaceuticals won FDA approval for neffy
Approval came on the back of four studies in 175 healthy adults without anaphylaxis. The studies measured the epinephrine concentrations in the blood following neffy treatment or approved epinephrine injection products.
Results demonstrated comparable epinephrine blood concentrations between neffy and approved epinephrine injection products. neffy also demonstrated similar increases in blood pressure and heart rate compared to epinephrine injection products. According to the FDA, these are two critical effects of the therapeutic in the treatment of anaphylaxis.
Additionally, a study of neffy in children above 66 pounds showed similar concentrations compared to adults who received neffy.
“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.”
