FDA accepts new drug application for epinephrine nasal spray

The FDA has accepted a new drug application for neffy, a nasal spray designed to treat type I allergic reactions without an injection in adults and children who weigh 30 kg or more, according to an ARS Pharmaceuticals press release.

FDA approval would make neffy (ARS-1, ARS Pharmaceuticals) the first noninjectable treatment available to patients with type I allergic reactions, such as anaphylaxis, according to the release.

“The FDA acceptance of our NDA for neffy is a major milestone in our efforts to bring to patients the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but in a needle-free and simple to administer nasal spray,” Richard Lowenthal, MS, MSEL (MBA), ARS Pharmaceuticals president and CEO, said in the press release.

According to the company, neffy is an aqueous formulation of epinephrine nasal spray uniquely developed with Intravail (Neurelis), which ARS Pharmaceuticals called a novel nasal absorption-enhancing technology.

The new drug application is supported by four primary registration studies during which a 2 mg intranasal dose of neffy met all clinical endpoints. Also, the nasal spray’s pharmacokinetics were within the range of approved epinephrine injection products.

These studies included adults who administered neffy to themselves and who received the nasal spray from caregivers, in addition to children with type I allergies who weighed 30 kg or more.

Further, administration was well tolerated, as more than 500 individuals received at least one dose and many had repeat administration. Most of the adverse events in these trials were mild and did not include any meaningful nasal irritation or pain, according to ARS Pharmaceuticals.

According to the press release, due to the fast onset of potentially life-threatening allergic reactions, neffy’s spray mechanism could enable more rapid administration of epinephrine with less hesitation than injectable approaches. ARS Pharmaceuticals cited the spray’s user-friendly and portable design as additional benefits.

The FDA has assigned a Prescription Drug User Fee Act target action date in the middle of 2023.

Reference:

• ARS Pharmaceuticals raises $55 million in series D funding for launch preparations of neffy (epinephrine nasal spray). https://ars-pharma.com/2021/08/31/ars-pharmaceuticals-raises-55-million-in-series-d-funding-for-launch-preparations-of-neffy-epinephrine-nasal-spray/. Published Aug. 31, 2021. Accessed Oct. 24, 2022.