ARS Pharmaceuticals (SPRY) Announces Availability of Briefing Documents for FDA Advisory Committee Meeting on neffy® for the Treatment of Type I Allergic Reactions Including Anaphylaxis

ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the Pulmonology, Allergy-Drugs Advisory Committee (PADAC) meeting to review the new drug application (NDA) for neffy®. neffy has the potential to be the first, non-injectable epinephrine nasal spray medicine for the treatment of patients with allergic reactions (type 1), including anaphylaxis.

The advisory committee meeting is scheduled to begin at 9:00 AM ET on May 11, 2023. Briefing materials, including FDA’s addendum to the documents, and webcast information for the meeting can be accessed at https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-11-2023-pulmonary-allergy-drugs-advisory-committee-meeting-announcement-05112023#event-materials. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.

“We are confident in the robust data package with neffy and believe our submission contains the information FDA indicated would be appropriate to support a potential approval of the first-ever non-injectable epinephrine spray,” said Richard Lowenthal, Co-Founder, President and Chief Executive Officer at ARS Pharma. “We look forward to discussing this information with the PADAC members and presenting the details of our clinical findings across multiple registrational studies later this week.”

ARS’s NDA submission was based on data from four primary registrational studies showing that 2.0 mg intranasal dose of neffy met all clinical endpoints recommended by FDA and that its pharmacokinetics were within the range of approved epinephrine injection products. These data included studies in adults, with self-administration and caregiver administration, as well as in children with Type I allergies ≥30 kg (66 lbs). In addition, neffy has been well-tolerated to date with more than 600 individuals in clinical trials receiving at least one dose, and many with repeat administration. 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.

The Company’s NDA submission for neffy was accepted for review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date anticipated in mid-2023.

About Type I Allergic Reactions including AnaphylaxisType I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 25 to 40 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency.

About ARS Pharmaceuticals, Inc.ARS is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The Company is developing neffy® (also referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis. For more information, visit www.ars-pharma.com.

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