The U.S. Food and Drug Administration (FDA) has delayed approval for an epinephrine nasal spray called neffy, which is intended for the treatment of allergic reactions. The FDA cited the need for further trial data as the reason for the delay. Richard Lowenthal, the CEO of ARS Pharma, the manufacturer of neffy, expressed disappointment over the delay, stating, "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."
Neffy is a needle-free nasal spray epinephrine treatment that offers a more easily carried and administered solution for severe allergic reactions. Lowenthal highlighted the importance of neffy for patients, caregivers, and physicians, and expressed a commitment to completing the requested trial as quickly as possible to meet the needs of patients.
The FDA's decision to delay approval for neffy comes after the agency rejected the treatment on September 19. The rejection was based on the requirement for a trial assessing the effectiveness of repeat doses of neffy compared to repeat doses of an epinephrine injection in treating allergen-induced rhinitis. The completion of this trial is necessary before the FDA will support the approval of neffy as an allergy treatment.
Interestingly, the FDA Advisory Committee (PADAC) had recommended in May 2023 to approve neffy without requiring additional studies to prove its effectiveness or safety. However, the FDA's decision to delay approval contradicts the PADAC's recommendation. During the PADAC meeting, neffy was found to have a favorable benefit-risk profile for the treatment of patients with allergic reactions.
Richard Lowenthal expressed surprise and disappointment regarding the FDA's decision to change the status of the repeat-dose study for neffy from a post-marketing requirement to a pre-approval requirement. He emphasized that the data package for neffy was comprehensive and generated in collaboration with the FDA, and he believes in the significant value that neffy can offer to patients, families, and caregivers dealing with severe allergic reactions.
The delay in approval for neffy has caused frustration among patient, advocacy, and physician communities who are eagerly waiting for this needle-free alternative for treating severe allergic reactions. The hope is that the requested trial will be completed quickly so that neffy can become available to the millions of people at risk of potentially life-threatening allergic reactions.
