The FDA has approved ARS Pharmaceutical’s NDA for Neffy epinephrine nasal spray for the treatment of Type 1 allergic reactions, including anaphylaxis, in patients who weigh 30 kg or greater. In response, ARS Pharma announced that the product should be available in the US within 8 weeks and also said that it plans to submit an sNDA seeking approval for the use of Neffy in pediatric patients who weigh at least 15 kg within the next few months.
The FDA’s Pulmonary-Allergy Drug Advisory Committee (PADAC) voted to support approval of the NDA in May 2023; however, in September of that year, the agency issued a complete response letter to the NDA, requesting a PK/PD repeated-dose study prior to approval. ARS announced in February 2024 that it had completed the study and the company announced the submission of its response to the CRL in April 2024.
FDA Associate Director of the CDER Division of Pulmonology, Allergy and Critical Care Kelly Stone commented, “Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections. The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, Neffy provides an important treatment option and addresses an unmet need.”
Neffy is a single-dose product delivered via Aptar Pharma‘s Unidose (UDS) device. According to ARS Pharma, the nasal spray has a shelf life of 30 months and can still be used after being frozen or after exposure to temperatures as high as 122°F / 50°C. ARS Pharma says that it will offer a co-pay savings program that will result in most patients with insurance paying $25 for 2 doses of Neffy and says that uninsured patients may qualify for a program to purchase 2 doses for $199 cash.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “This approval marks a watershed moment in addressing an unmet medical need for people with Type 1 allergies, a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many. Epinephrine treatment is only effective if available, readily usable, and administered appropriately. Our team has worked tirelessly to create an easy-to-carry, easy-to-use, needle-free device that offers peace of mind to patients and caregivers by enabling them to administer epinephrine quickly and confidently when needed. We thank the FDA staff for their partnership and support in the development of Neffy, and are deeply grateful to the severe allergy community, including advocates, patients, parents, and healthcare professionals, for their contributions to the development of Neffy as an important, life-saving treatment.”
In the EU, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recently recommended approval of the nasal spray, which ARS expects to be approved and launched by the end of the year.
Read the FDA press release.
Read the ARS Pharmaceuticals press release.
