22 Sept 2023 • The Food and Drug Administration, in a surprise move, has decided not to approve an epinephrine nasal spray that would have been the first needle-free alternative to epinephrine autoinjectors, including EpiPens. In a rare turn of events, the rejection came despite the agency’s advisory committee voting in May to recommend approval of the drug in children and adults. A major point of concern during the advisory committee meeting in May was a lack of clinical data, particularly that the drug was not studied in people experiencing anaphylaxis.

The FDA has requested an additional study comparing Neffy to an epinephrine autoinjector in people with allergen-induced nasal symptoms including sneezing, itching and congestion. The drugmaker said it plans to resubmit its application to the FDA in the first half of 2024. The company is seeking an indication for epinephrine nasal spray as the first non-injectable treatment for type 1 allergic reactions, such as anaphylaxis.

The FDA said a pharmacokinetic/pharmacodynamic study, assessing repeat doses of the nasal spray compared with repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions, will be needed to support approval -- not as a postmarketing commitment, as previously suggested by the agency.

Source: WebMD | Read full story