ARS Pharma’s neffy on Friday became the first FDA-approved nasal spray to address severe allergic reactions, including those that might lead to life-threatening anaphylaxis.
The FDA on Friday signed off on ARS Pharmaceuticals’ epinephrine nasal spray, which will now carry the brand name neffy, for the treatment of severe allergic reactions—making it the first approval of an epinephrine product for the treatment of anaphylaxis that is not administered by injection.
Neffy is indicated for type I allergic reactions, which are those mediated IgE antibodies and are usually triggered by food, insect bites and other medications, leading to systemic or localized anaphylaxis—which can be life-threatening. The approval is for use in children and adults who weigh at least 30 kg.
ARS Pharma CEO Richard Lowenthal in a statement called neffy’s approval “a watershed moment,” providing patients and their doctors with “a treatment alternative that avoids the need to inject epinephrine with a needle.” The company has enough money to support the launch of neffy, with nearly $219 million in cash, cash equivalents and short-term assets, according to its second-quarter 2024 business report.
Neffy will be available in the U.S. “within eight weeks” of the approval and will be available for $25 for “most commercially insured patients,” The ARS Pharma announced. For eligible patients without insurance coverage, the nasal spray will be priced at $199 for two doses on BlinkRx and GoodRx.
Friday’s approval is backed by five primary registrational studies and several pilot and other supportive studies in which neffy aced all of its defined clinical endpoints. The nasal spray product showed a pharmacokinetic (PD) and pharmacodynamic (PD) profile that matched approved injectable epinephrine products, according to the company.
In terms of safety, neffy’s side effects were generally mild and the nasal spray did not cause meaningful nasal irritation of pain. There were also no serious toxicities detected in its clinical development program.
ARS Pharma initially filed its drug application for neffy in 2022, even securing the strong backing of the FDA’s Pulmonary-Allergy Drugs Advisory Committee, which in May 2023 voted 16-6 in favor of approval. However, the FDA rejected the application and issued a Complete Response Letter in September 2023, along with the request for an additional PK/PD study of repeated doses of neffy versus injected epinephrine product under allergic rhinitis conditions.
The regulator previously flagged the lack of clinical data to support neffy’s applications. In a briefing document ahead of the advisory committee meeting, internal reviewers pointed out that relying on neffy’s PK/PD profiles compared with injected products could result in “uncertainties,” particularly as the nasal mucosa might affect neffy’s absorption.
