The Food and Drug Administration decided not to approve Neffy, an epinephrine nasal spray developed by ARS Pharmaceuticals, which means that the first needle-free option for treating severe allergic reactions won’t be available to the American market until more trial data is gathered. ARS had anticipated the FDA’s approval for Neffy’s use in adults and children who weigh over 30 kilograms. Similar to EpiPens and other epinephrine injections, the spray would have required a prescription. Neffy, if approved, would have offered an alternative to families with children who suffer from severe allergies and wish to avoid needles. However, the FDA requested further data on the safety of repeated doses of the nasal spray before granting approval.
ARS Pharmaceuticals expressed surprise and disappointment over the FDA’s decision to require a pre-approval trial, as they had previously aligned with the FDA on a post-marketing requirement. The drugmaker aims to complete the new trial quickly to meet the needs of patients waiting for Neffy. The CEO of ARS Pharma, Richard Lowenthal, had previously highlighted the barriers faced by patients when using epinephrine, such as fear of needles, discomfort with self-injection, and the inconvenience of carrying current available devices. He presented data suggesting that if Neffy were an option, approximately 85% of patients with severe allergies would be willing to carry epinephrine with them daily compared to the current rate of around 55%.
Neffy nasal spray utilizes two other technologies used in other FDA-approved products: dodecylmaltoside, which enhances drug absorption through mucous membranes, and a sprayer device sold by Aptar Pharma. Epinephrine nasal sprays from other drugmakers are also in development, including Bryn Pharma’s experimental spray Utuly, which has shown promising results.
The FDA’s request for more data is just one of the delays faced by ARS in bringing Neffy to market. The company had originally anticipated approval by mid-2023 but was informed by the FDA that they needed until September to make a decision. The FDA’s Pulmonary-Allergy Drugs Advisory Committee had shown majority support for the benefits of Neffy outweighing its risks, although questions had been raised regarding its effectiveness compared to injections. While experts widely accept epinephrine’s efficacy in treating severe allergic reactions, its original use predates clinical trials. The original EpiPen was approved without clinical trials, leading to a lack of detailed data on how the drug is absorbed and its effects on the body.
ARS Pharmaceuticals conducted various studies to generate surrogate data to determine Neffy’s potential effectiveness compared to injections. However, conflicting data and varied results made it challenging to prove the effectiveness of delivering epinephrine as a spray. Some FDA committee members expressed the need for more clinical data before approving the drug to ensure patient safety.
In conclusion, the FDA’s decision not to approve Neffy has caused a delay for ARS Pharmaceuticals, who now need to gather additional trial data. The drugmaker remains optimistic about meeting the needs of patients suffering from severe allergies and aims to provide a needle-free alternative as quickly as possible.
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