According to a recent CBS News article, the FDA’s outside advisers voted in favor of a needle-free epinephrine nasal spray product called Neffy, that could soon be the first of its kind to treat severe allergic reactions. The nasal spray is designed to deliver a 2mg dose of epinephrine capable of reversing life-threatening symptoms of an allergic reaction. The company is seeking FDA approval for anyone weighing over 30 kg (~66 lbs).
The FDA had asked the committee whether it should require more studies for the drug, which had aimed to bypass large clinical trials by comparing it to similar, previously approved injection products that treat allergic reactions. The drugmaker hopes Neffy will fill a key unmet need for people who are at risk of severe allergic reactions but are uncomfortable with the injection options currently on the market.
