ARS Pharmaceuticals Announces Scheduling Of A Type A Meeting With The U.S. FDA By The End Of October For neffy (Epinephrine Nasal Spray)

Author: Benzinga Newsdesk | October 06, 2023 09:04am

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced that the United States (U.S.) Food and Drug Administration (FDA) has scheduled a Type A meeting to discuss the contents of a Complete Response Letter (CRL) previously issued regarding its new drug application (NDA) for neffy® (epinephrine nasal spray) for the treatment of allergic reactions (Type I), including anaphylaxis.

 

The Type A meeting with FDA will be held by the end of October.

"Patients and caregivers are waiting for neffy to be approved and have expressed to us disappointment with the delay in the FDA approval. We intend to work with FDA to meet the critical need for a needle-free epinephrine treatment as quickly as possible. Millions of people are at risk of a potentially life-threatening severe allergic reaction, and in practice, many are without any treatment option today, due to their inability to carry, or hesitancy or refusal to inject epinephrine in a timely manner. We are committed to meeting this urgent unmet medical need," said Richard Lowenthal, Co-founder, President, and CEO of ARS Pharma. "We were surprised by the late decision of FDA to request an additional study, based on prior discussions with FDA that this study could be conducted post approval, as informative for labeling. We are moving rapidly to conduct the study and look forward to the Type A meeting, which will provide an opportunity to discuss the CRL and pathway forward with FDA."

In May 2023, an FDA Advisory Committee (the Pulmonary-Allergy Drugs Advisory Committee (PADAC)) concluded a favorable benefit-risk profile and recommended approval of neffy. Multiple PADAC members highlighted the favorable profile of neffy in our completed single-dose nasal allergen challenge study, which showed enhanced absorption during the time period when a clinical response would be expected. No member of the Committee requested a repeat dose study with neffy during allergen-induced allergic rhinitis, and ARS Pharma aligned with FDA in May 2023 and re-confirmed in August 2023 that such a study could be completed as a post-marketing requirement and had also aligned on final physician labeling.

Lowenthal added, "It is important to remember that there are less than 5% of food allergy cases where some degree of rhinitis is present and the unmet medical need and urgent benefit of neffy in the community are for those that are unwilling to accept a prescription for an injection device or who don't carry or use their epinephrine autoinjector when they experience an allergic reaction."

An estimated 45% of severe allergy patients do not fill their epinephrine prescriptions, and among the 3.3 million people who do obtain an injection device, more than 50% do not carry their autoinjector devices with them and 25% to 50% do not use it when presented with a serious allergic event.

Clinical data from a rigorous registration program of more than 600 subjects demonstrated that neffy achieved both a pharmacokinetic (PK) and pharmacodynamic (PD) profile that is comparable to approved injection products as well as a safety profile that is well-tolerated, but without needle-related risks. The company plans to complete a repeat dose study with neffy in allergen-induced allergic rhinitis and file its NDA resubmission to the FDA in the first half of 2024, with an anticipated launch of neffy, if approved, in the second half of 2024.

About Type I Allergic Reactions, including Anaphylaxis

Type 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 40 million people in the United States who experience Type I severe allergic reactions due to food, venom, or insect stings. 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.

Posted In: SPRY