The U.S. Food and Drug Administration has requested further studies by ARS Pharmaceuticals on its neffy treatment before it will approve its use. Photo courtesy of ARS /Website
Sept. 20 (UPI) -- Federal regulators have declined to approve the first needle-free epinephrine treatment for people who suffer from severe allergic reactions, requesting its developer, ARS Pharmaceuticals, to conduct further testing.
The late Tuesday announcement by ARS Pharmaceuticals follows expectations that the Food and Drug Administration was to sign off on neffy after its Pulmonary-Allergy Drug Advisory Committee in May voted 16:6 in favor of adults and 17:5 in favor for children younger than 18 years of age and greater than around 66 pounds.
"We are very surprised by this action," Richard Lowenthal, co-founder, president and chief executive of ARS Pharmaceuticals, said in a statement.
"We stand by the totality of the neffy data package generated in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value neffy can provide for patients, families and caregivers living daily with severe allergic reactions."
Neffy is an epinephrine treatment used to combat severe allergic reactions similar to EpiPen. But, unlike EpiPen, which administers epinephrine via injection, neffy is a nasal spray.
The California-based pharmaceutical said the FDA had issued it a Complete Response Letter, requiring a repeat-dose study of the nasal spray before it can be approved despite it and the federal regulator having agreed in August that such a study would be conducted after it hit the market.
It said it expects to resubmit its application in the first half of next year, which will position neffy for FDA action during the calendar's latter half.
"We are deeply disappointed that this action further delays the availability of neffy for the millions of people who are at risk of a potentially life-threatening severe allergic reaction," Lowenthal said.