September 20, 2023 – The FDA has requested further studies before approving a nasal spray version of the allergy medication epinephrine.
The nasal spray called Neffy from ARS Pharmaceuticals could be the primary needle-free option for emergency allergic reactions and an alternative choice to the widely used EpiPen. ARS Pharmaceuticals announced the FDA's decision in a Press release on Tuesday, noting that an FDA advisory panel had beneficial approval in May.
“We are very surprised by this action and the late request to convert the repeat dose study from a post-marketing requirement that we had previously agreed with the FDA to a pre-approval requirement, especially given the positive vote of the Advisory Committee,” company founder, President and CEO Richard Lowenthal said in a press release.
The news agency Reuters reported that the manufacturer of the competing product EpiPen asked the FDA in June to require ARS Pharmaceuticals to conduct further tests.
Epinephrine is used to treat life-threatening allergic reactions that may be attributable to insect stings or bites, foods, medications and other causes, in accordance with the Federal Drug Database. Medline Plus. Adrenaline relaxes the respiratory muscles and constricts the blood vessels.
Earlier this yr, NBC News reported that the price of EpiPens has risen from $30 per pen to $600 per pen in recent times. Drug price-tracking website GoodRx lists the brand-name pens at about $600, while generics can be found for as little as $108.
The Food Allergy Research and Education (FARE) group criticized the FDA's move.
“For 36 years, the only treatment for food allergies was to forcefully stick a needle from an epinephrine auto-injector into the patient’s thigh,” said FARE Executive Director Sung Poblete, PhD, RN, in a opinion“Our community believed this innovation would finally benefit the more than 10 percent of Americans who suffer from life-threatening food allergies, but instead the FDA is forcing us to wait even longer.”
ARS Pharmaceutical said it plans to resubmit its regulatory filing in the primary quarter of 2024.