FDA asks ARS Pharma for more testing in epinephrine nasal spray approval process
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Key takeaways:
- Neffy treats type 1 allergic reactions in adults and children who weigh 30 kg or more.
- ARS Pharma will appeal the FDA’s decision and resubmit its new drug application once new testing is complete.
The FDA has issued a complete response letter to ARS Pharma concerning its new drug application for neffy epinephrine nasal spray, according to a press release from the company.
The spray is designed to treat type 1 allergic reactions including anaphylaxis in adults and children who weigh 30 kg and more.
The letter asked ARS Pharma to complete a pharmacokinetic and pharmacodynamic study to assess repeat doses of neffy compared with repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval.
Also, the letter asked for additional information about nitrosamine impurities that will be tested based on new draft guidance that was issued after ARS Pharma submitted its new drug application for neffy.
ARS Pharma said that it does not believe that the additional testing would be a rate-limiting step for its resubmission to the FDA, but it also said that it will submit a formal dispute resolution request to appeal the complete response letter.
In May 2023, the FDA Pulmonary-Allergy Drug Advisory Committee recommended neffy’s approval without any need for additional studies demonstrating its efficacy or safety, nor did it express any concerns about a completed study of patients with allergen-induced acute rhinitis receiving a single dose of neffy and experiencing enhanced absorption during the time period when a clinical response would be expected.
Also, in August, ARS Pharma said that it aligned with the FDA on final physicians’ labeling and on a post-marketing requirement for conducting the requested study as informative for labeling.
“We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote,” Richard Lowenthal, MS, MSEL, cofounder, president and CEO of ARS Pharma, said in the press release.
“In fact, multiple committee members highlighted the favorable profile of neffy in our completed single-dose nasal allergy challenge study and that any decline in exposure 20 minutes after dosing, after the expected response period, is of no concern,” he continued.
Lowenthal noted that the company stands behind the totality of its data package and believes in the spray’s potential to support patients, families and caregivers who live with allergy.
“If approved, neffy would represent the first needle-free nasal spray epinephrine treatment for people with severe allergic reactions that has been shown to be more easily carried and administered, without anxiety or hesitation, which is critical to stopping disease progression,” he said.
“Patients and caregivers are waiting for neffy, and we aim to complete the newly requested trial as quickly as possible to meet the needs of patients,” he said.
Sung Poblete, RN, PhD, CEO of Food Allergy Research & Education (FARE), expressed her organization’s disappointment with the FDA’s decision as well.
“For 36 years, the food allergy community’s only treatment option has been to forcefully insert a needle from an epinephrine autoinjector into the thigh of the patient,” Poblete said in a statement.
“Our community believed this innovation would finally come to the more than 10% of Americans with life-threatening food allergies, but instead, the FDA will force us to wait even longer,” she continued.
ARS Pharma expects to resubmit its new drug application to the FDA in the first half of 2024, once the repeat-dose study has been completed, with anticipated FDA action in the second half of 2024.
Reference:
- FARE. Statement by Song Poblete, RN, PhD, CEO of FARE, regarding the frustration felt by the food allergy community after FDA requests additional information and testing before approving neffy, a needle-free epinephrine alternative. https://www.foodallergy.org/media-room/statement-sung-poblete-rn-phd-ceo-fare-regarding-frustration-felt-food-allergy-community. Published: Sept. 19, 2023. Accessed: Sept. 20, 2023.