FDA refuses to okay first nasal spray for allergic reactions, firm says

, concluding that data presented by ARS showed the benefits of the product outweighed the risks. The vote was 16-6 in favor of approving the drug for adults and 17-5 for children 66 pounds and over. The FDA usually follows the advice of its outside advisers but is not required to do so.

ARS has said it submitted information to the FDA showing that Neffy delivered a level of epinephrine consistent with the auto-injector devices and that the way the drug acted in the body was similar to or better thanThe company said in its statement Tuesday that the FDA has asked for more research assessing repeat doses of Neffy compared with repeat doses of an injection product. Lowenthal said the FDA previously had indicated that such a study could be conducted after approval.

In June, Viatris, the company that makes EpiPen, disagreed, filing a citizen petition with the FDA asking the agency to require ARS Pharmaceuticals to conduct more studies. Viatris was formed in 2020 by the merger of Mylan and Upjohn.

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