September 20, 2023 – The FDA has requested more studies before approving a nasal spray version of the drug epinephrine for allergic reactions.
ARS Pharmaceuticals' nasal spray, called Neffy, could be the primary needle-free option for emergency allergic reactions and a substitute for the widely used EpiPen. ARS Pharmaceuticals announced the FDA's decision in a Press release on Tuesday, noting that an FDA advisory panel had advisable approval in May.
“We are very surprised by this action and the late requirement to convert the repeated-dose study from a post-marketing requirement, which we previously agreed with the FDA, to a pre-approval requirement, especially given the positive results Recommendation.” Vote in committee,” company founder, president and CEO Richard Lowenthal said in an announcement.
The Reuters news agency reported that the maker of competing product EpiPen asked the FDA in June to require ARS Pharmaceuticals to conduct further testing.
According to the federal drug database, epinephrine is used to treat life-threatening allergic reactions that may be attributable to insect bites or stings, foods, medications and other causes Medline Plus. Adrenaline relaxes the respiratory muscles and constricts the blood vessels.
Earlier this yr NBC News reported that the fee of EpiPens has increased from $30 per pen to $600 per pen in recent times. On drug price tracking website GoodRx, the brand-name pens are listed for around $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 option for food allergy sufferers has been to forcibly insert a needle from an epinephrine auto-injector into the patient’s thigh,” FARE CEO Sung Poblete, PhD, RN, said in a opinion. “Our community believed this innovation would finally reach 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 regulatory submission in the primary quarter of 2024.