ARS Pharma submits response letter to FDA after further nasal epinephrine study
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Key takeaways:
- The FDA asked ARS Pharma to study results under nasal allergen challenge conditions.
- Responses to neffy with these conditions were similar to or greater than responses to intramuscular injection.
ARS Pharma has submitted a complete response letter to the FDA as it seeks approval for its neffy epinephrine nasal spray, which is designed to treat type I allergic reactions such as anaphylaxis, according to a company press release.
“Based on multiple meetings with the FDA, we believe that we have responded fully and completely to the agency’s concerns and appreciate its insights along the way,” Richard Lowenthal, cofounder, president and CEO of ARS Pharma, said in the release.
In August 2022, the company submitted its New Drug Application for neffy to the FDA. An advisory committee determined that neffy had a favorable benefit-risk profile for both children and adults in May 2023.
But in September 2023, the FDA issued a complete response letter that asked ARS Pharma to study the pharmacokinetic (PK) and pharmacodynamic (PD) effects of repeat doses of neffy on patients experiencing nasal allergen challenge conditions. None of the members of the advisory committee had requested such a study, according to ARS Pharma.
In addition, the FDA asked the company to complete updated nitrosamine testing per the FDA’s draft guidance, which was issued in August 2023.
In February, ARS Pharma announced that it had completed its clinical study comparing the PK and PD effects of repeat doses of neffy with repeat doses of intramuscular epinephrine with and without nasal allergen challenge conditions.
Results indicated that neffy’s PK and PD profiles were similar to or greater than intramuscular injection under these conditions. There also were greater exposures with repeat dosing in the same nostril compared with single doses in each nostril and with intramuscular injection at all time points.
“We will be publishing the repeat dose nasal allergen challenge study data in a scientific conference and/or peer-reviewed journal over the course of the next several months,” Justin Chakma, MBA, chief business officer at ARS Pharma, told Healio.
Further, ARS Pharma did not detect any measurable levels of nitrosamines in the additional testing requested by the FDA.
“Our focus on addressing any requests from the FDA to optimize our labeling remains critical in our mission to bring neffy to patients, providers and caregivers who continue to show substantial enthusiasm for a needle-free, safe, effective and easy-to-carry epinephrine solution,” Lowenthal said.
ARS Pharma expects the FDA review period to take up to 6 months, with a Prescription Drug User Fee Act date of Oct. 2.
“We look forward to working with the FDA in our efforts to make neffy available to allergy patients as soon as possible,” Lowenthal said.