Over the last 40 years, twin packs of EpiPens became a fixture for people and parents with children experiencing severe allergic reactions.
Now, ARS Pharmaceuticals hopes that a new intranasal option can take some of the market.
The FDA approved the nasal spray, to be known as neffy, on Friday to treat anaphylaxis in adults and children who are at least 66 pounds. It’s the first time ever that the FDA has approved a non-injectable epinephrine product, the agency said. The approval was based on data from four studies in healthy adults showing that neffy produced similar levels of epinephrine in the blood as injectable counterparts.
“The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis,” said Kelly Stone, associate director of the FDA’s Division of Pulmonology, Allergy and Critical Care, in a statement.
The announcement from the FDA comes almost two months before the agency’s decision deadline, originally set for Oct. 2. ARS Pharmaceuticals, maker of neffy, said in its second-quarter earnings report earlier this week that it was finalizing patient labeling.
The company’s shares $SPRY were up more than 11% on Friday afternoon and have jumped almost 20% in the last five days, sitting at about $11 per share. ARS has $218.7 million in cash, equivalents and short-term investments to help fund the US launch of neffy.
The FDA is following in the footsteps of European regulators who recommended its approval in late June. ARS says it’s on the hunt for a pharmaceutical partner to market the product in Europe and expects EURneffy will be available for patients in the fourth quarter of the year.
Almost a year ago, the FDA rejected neffy and requested additional data showing how patients responded after repeat doses. The product is meant to be administered one time in a single nostril but can be administered again if a patient isn’t responding or if the reaction gets worse. An FDA advisory committee in May 2023 voted in favor of neffy. At the time of the rejection, the company said it was “very surprised” by the additional requests, thinking that repeat dosing data would be a post-marketing requirement.
The label in the US comes with a warning that neffy could cause complications in patients with nasal conditions like polyps or a history of nasal surgery. It also warns patients with other certain coexisting conditions and allergies related to sulfite. The most common side effects included nasal irritation and tingliness, headache and throat irritation.