Sept. 20, 2023 – The FDA has requested further study before approving a nasal spray version of the allergic reaction medicine epinephrine.
Called Neffy, the nasal spray made by ARS Pharmaceuticals would be the first needle-free option for emergency allergic reactions and serve as an alternative to the widely used EpiPen. ARS Pharmaceuticals announced the FDA decision in a press release on Tuesday, noting that an FDA advisory panel had recommended approval in May.
“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,” said company founder, president, and CEO Richard Lowenthal in a statement.
The news agency Reuters reported that the maker of the competitor product EpiPen asked the FDA in June to require ARS Pharmaceuticals to conduct more testing.
Epinephrine is used to treat life-threatening allergic reactions that can result from insect bites or stings, foods, medications, and other causes, according to the federal drug database MedlinePlus. Epinephrine works by relaxing airway muscles and tightening blood vessels.
Earlier this year, NBC News reported that the cost of EpiPens had risen from $30 per pen in recent years to $600 per pen. The drug price-tracking website GoodRx lists the brand name pens at about $600, while generics are available for as low as $108.
The Food Allergy Research and Education (FARE) group criticized the FDA’s move.
“For 36 years, the food allergy community’s only treatment option has been to forcefully insert a needle from an epinephrine auto-injector into the thigh of the patient,” said FARE CEO Sung Poblete, PhD, RN, in a statement. “Our community believed this innovation would finally come to the more than 10 percent of Americans with life-threatening food allergies, but instead, the FDA will force us to wait even longer.”
ARS Pharmaceutical said it plans to resubmit its application for approval in the first quarter of 2024.
