Breaking News: FDA Denies Approval for Groundbreaking Needle-Free Alternative to EpiPen

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 announcement by ARS Pharmaceuticals on Tuesday came as a surprise, considering the expectations that the Food and Drug Administration would approve neffy after its Pulmonary-Allergy Drug Advisory Committee voted in favor of adults and children using the nasal spray.

“We are very surprised by this action,” said Richard Lowenthal, co-founder, president and chief executive of ARS Pharmaceuticals, in a statement.

Despite the comprehensive registration program and data package generated for neffy, the FDA issued a Complete Response Letter to ARS Pharmaceuticals, requiring a repeat-dose study of the nasal spray before granting approval. This requirement was contrary to the agreement made between ARS Pharmaceuticals and the FDA in August, where it was decided that the study would be conducted after the nasal spray’s market launch.

ARS Pharmaceuticals plans to resubmit its application in the first half of next year, with hopes of FDA action in the latter half of the year. However, the delay in approval is disappointing for the millions of people at risk of severe allergic reactions who could benefit from neffy.

Neffy is an epinephrine treatment, similar to EpiPen, used to combat severe allergic reactions. While EpiPen administers epinephrine through injection, neffy is a nasal spray.

Richard Lowenthal emphasized the value of neffy for patients, families, and caregivers living with severe allergic reactions, expressing ARS Pharmaceuticals’ commitment to its development and eventual approval.