FDA Approves Nasal Spray Neffy as First Needle-Free Treatment for Anaphylaxis

The Food and Drug Administration (FDA) has taken a significant step forward in the treatment of severe allergic reactions by approving Neffy, a nasal spray, as the first needle-free alternative to traditional epinephrine auto-injectors like the EpiPen. This approval marks a pivotal moment for individuals who suffer from severe allergies to food, medications, or insect stings, providing them with a more user-friendly option for emergency treatment. Neffy, developed by ARS Pharmaceuticals, is designed to be administered as a single-dose spray into one nostril, offering a quick and less intimidating method for delivering life-saving medication during an anaphylactic reaction.

Neffy works by delivering a 2-milligram dose of epinephrine through the nasal passage, which is absorbed into the bloodstream to counteract the severe allergic reaction. This new method of administration is particularly beneficial for individuals who have a fear of needles, a common barrier that can delay or prevent timely treatment. According to FDA Associate Director Kelly Stone, the fear of injections is especially prevalent among children, who may hesitate or refuse to use an auto-injector during a critical moment. By offering a needle-free alternative, Neffy aims to reduce this hesitation and ensure that individuals receive the necessary treatment promptly.

Anaphylaxis is a rapid and severe allergic reaction that can occur within seconds or minutes of exposure to an allergen. Symptoms can include airway constriction, low blood pressure, and potentially life-threatening respiratory failure. The speed at which anaphylaxis can progress makes immediate access to treatment essential. Traditional auto-injectors like the EpiPen have been the standard treatment for decades, but their needle-based delivery system can be a significant drawback for many patients. Neffy addresses this issue by providing a simpler and less invasive method of administration, which could lead to better outcomes in emergency situations.

The approval of Neffy was based on four clinical studies involving 175 healthy adults who were not experiencing anaphylaxis at the time of testing. These studies compared the concentration of epinephrine in the blood after using Neffy to that of traditional epinephrine injection products. The results showed that the levels of epinephrine achieved with Neffy were comparable to those obtained with an auto-injector, demonstrating its efficacy in delivering the medication. Despite initial hesitation from the FDA, which requested additional data last year, the approval was ultimately granted, providing a new option for those at risk of severe allergic reactions.

ARS Pharmaceuticals believes that Neffy represents a significant advancement in the treatment of anaphylaxis. Richard Lowenthal, CEO of ARS Pharmaceuticals, stated that Neffy will help people with severe allergies live more normal lives by overcoming the fear and hesitation associated with needle-based treatments. The company has also emphasized the convenience and ease of use of Neffy, which is expected to make it a popular choice among patients and caregivers. Neffy will be available in a pack of two single-use devices, ensuring that individuals have a backup dose if needed.

The cost of Neffy is expected to be comparable to that of branded auto-injectors, with a list price to be released soon. For individuals with commercial insurance, the co-pay will be $25 with coupons, while the cash price will be $199. ARS Pharmaceuticals has also announced a patient assistance program to help those with high out-of-pocket costs or no insurance coverage, ensuring that the medication is accessible to everyone who needs it. The company expects Neffy to be available in the United States within eight weeks, making it a timely addition to the options available for treating anaphylaxis.

In addition to its practical benefits, Neffy also offers a longer shelf life compared to traditional auto-injectors, with a duration of up to 30 months. This extended shelf life can provide peace of mind for individuals who may not need to use the medication frequently but still require it to be effective when needed. The nasal spray device used for Neffy is similar to that of Narcan, a naloxone nasal spray used for opioid overdose, which has already proven to be an effective and reliable method of drug delivery. This similarity further supports the potential success of Neffy in the market.

While the approval of Neffy is a significant milestone, it is important to note that it is not a substitute for seeking medical attention during an anaphylactic episode. The FDA recommends that individuals who use Neffy still seek emergency medical assistance for close monitoring and further treatment if necessary. This dual approach ensures that patients receive the immediate benefits of the nasal spray while also addressing any additional medical needs that may arise during an allergic reaction.

The introduction of Neffy is expected to improve emergency response and outcomes for people at risk of anaphylaxis. By providing a needle-free option, it removes a major barrier to treatment and increases the likelihood that individuals will administer the medication promptly. This can be particularly important in situations where every second counts, and the availability of a user-friendly option can make a significant difference in the outcome of an allergic reaction.

Neffy’s approval also highlights the ongoing efforts to innovate and improve the treatment options available for severe allergies. While epinephrine has been used for over a century, the development of a nasal spray formulation represents a modern advancement that aligns with the needs and preferences of today’s patients. This progress is a testament to the importance of continued research and development in the field of allergy treatment, ensuring that individuals have access to the most effective and convenient options available.

The next challenge for ARS Pharmaceuticals will be to ensure that Neffy is as widely available as traditional auto-injectors like the EpiPen. This will involve working with healthcare providers, pharmacies, and insurance companies to integrate Neffy into the existing framework of allergy treatment. By doing so, the company hopes to make Neffy a standard option for individuals at risk of anaphylaxis, providing them with a reliable and accessible method of emergency treatment.

Overall, the approval of Neffy by the FDA represents a significant advancement in the treatment of severe allergic reactions. By offering a needle-free alternative to traditional auto-injectors, Neffy addresses a major barrier to timely treatment and provides a more user-friendly option for individuals at risk of anaphylaxis. With its expected availability in the coming weeks, Neffy is poised to become a valuable tool in the management of severe allergies, helping to save lives and improve outcomes for those affected by this potentially life-threatening condition.