neffy Nasal Spray Gets FDA Nod

For the 40 million Americans who suffer from severe allergic reactions, FDA’s recent approval of neffy should come as a relief. The epinephrine nasal spray from ARS Pharmaceuticals is the first and only needle-free treatment for type 1 allergic reactions, including anaphylaxis.

Use of auto-injectors can cause anxiety among people who fear needles, deterring the use of life-saving medicine during a severe allergic reaction. neffy offers an alternative treatment for those who suffer allergies but are averse to using a needle. It uses the same pocket-size device as both the prescription and over-the-counter versions of Narcan nasal spray, which is used to treat opioid overdoses. The secondary packaging for neffy is also similar to Narcan’s: It consists of two blisters containing the individual sprayers in a carton; however, the overall dimensions are different. 

“The nasal spray device is designed to deliver a single, precise dose in virtually any situation without the need for invasive injections,” says Brian T. Dorsey, MSc, chief operating officer, ARS Pharmaceuticals. “It is very simple to use and can be administered by caregivers, family, or even the patient themselves. ARS has conducted several human factors studies to demonstrate the ease of use by patients and caregivers under various conditions.” 

Related:FDA Halts Approval of Neffy Nasal Spray for Epinephrine

The nasal sprayer — an “off-the-shelf nasal atomizer,” according to The Washington Post — has been in the market since 2015 when prescription Narcan received FDA approval. ARS Pharmaceuticals did not disclose its supplier by our deadline but Aptar has Unidose/Bidose nasal delivery systems that look identical.

neffy nasal spray has a 30-months shelf life and can survive temperature exposure up to 122°F (50°C), making it a “potentially effective treatment if left in a car or outside for a length of time,” according to ARS Pharmaceuticals. “If accidentally frozen, neffy can be thawed and administered.”

Last year, FDA rejected ARS Pharmaceuticals’ new drug application for neffy. To support approval, the agency requested further testing to assess repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions.

neffy 2 milligrams has been approved for use in adults and children who weigh 66 pounds or more. The approval marks the first significant innovation in the delivery of epinephrine in more than 35 years.