| Item 7.01 | Regulation FD Disclosure. |
Furnished as Exhibit 99.1 to this report is a Company presentation, which is being presented by the Company beginning at 8:00 a.m. Eastern Time on August 12, 2024.
The information in Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
FDA Approval of neffy® (epinephrine nasal spray)
On August 9, 2024, ARS Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in adults and children who weigh ≥30 kg.
The approval of neffy is based on data from five primary registration studies with a 2 mg intranasal dose of epinephrine. These primary clinical trials were supported by numerous pilot and supportive studies. neffy met all defined clinical endpoints and its pharmacokinetic and pharmacodynamic data were within the range of approved epinephrine injection products. These data included single- and twice-dosed studies in healthy adults, with self-administration and caregiver administration in Type I allergy patients, in pediatric patients ≥30 kg (66 lbs.) as well as in those with allergic rhinitis (congestion and runny nose). Adverse events in neffy clinical trials were generally mild in nature without any meaningful nasal irritation or pain, and no serious adverse events were reported in any clinical study.
neffy is expected to be available in the United States within eight weeks of FDA approval for patients who weigh greater than 30 kg (66 lbs.). The Company plans to file a supplemental NDA application with the FDA for neffy for children who weigh 15 to <30 kg by the end of the third quarter of 2024.
The European Committee for Medicinal Products for Human Use (the “CHMP”) adopted a positive opinion on June 27, 2024, recommending the granting of a marketing authorization for neffy (tradename EURneffy, in the European Union). The European Medicines Agency (“EMA”) decision is normally issued 67 days from the adoption of the CHMP opinion, and, if favorable, is followed by a grant of marketing authorization by the European Commission. Following the anticipated grant of marketing authorization by the European Commission expected in the third quarter of 2024, the Company anticipates that EURneffy will be made available to patients in Europe in the fourth quarter of 2024 by a pharmaceutical company with an already established commercial footprint in Europe.
Forward-Looking Statements
This report contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the timeline for neffy’s commercial availability; the Company’s plan to file a supplemental regulatory application for a neffy 1 mg product for children 15 kg to <30 kg; the timeline for potential regulatory approval and commercialization of EURneffy in Europe; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ
