FDA has recently approved neffy, the first epinephrine nasal spray for treating allergic reactions, paving the way for significant changes in how severe allergies are managed.
This approval, announced on August 9, 2024, is particularly important as it offers adults and children over 66 pounds a needle-free alternative to traditional epinephrine injections.
The nasal spray, developed by ARS Pharmaceuticals, is touted as a game-changer for those suffering from potentially fatal allergic reactions, including anaphylaxis.
Richard Lowenthal, CEO of ARS Pharmaceuticals, expressed his excitement about this milestone, noting how this aligns with their commitment to the allergy community.
He added, "The advancement of medical innovation is never a straight line," acknowledging the challenges faced along the way.
Neffy is considered to fill a notable gap, as many patients fear injections, which can lead to delays or avoidance of necessary treatment.
Both the FDA and ARS Pharma are optimistic about using this nasal spray as the leading epinephrine treatment due to its ease of use.
The approval was based on four clinical studies with 175 healthy adults, focusing on the pharmacokinetics and dynamics of epinephrine delivery.
Compared to traditional injections, studies showed neffy achieves comparable blood concentrations of epinephrine, making it effective for combating severe allergic reactions.
Clinical trials also confirmed similar epinephrine levels for children over 66 pounds so they can benefit from this new delivery method.
Neffy is administered as a single spray inside one nostril, with the option for caregivers to use another dose if symptoms persist.
Importantly, medical assistance should still be sought during severe allergic reactions to monitor and stabilize the patient.
Alongside FDA approval, ARS Pharma plans to expand the product's use to include younger patients, targeting those weighing less than 66 pounds.
This strategy includes developing new dosages and devices meant for even smaller children.
Becoming available at pharmacies, the cost for two doses of neffy will be about $199, but digital pharmacy partnerships may offer discounts for uninsured patients.
Market experts predict neffy could rapidly capture market share, with estimates indicating peak sales could surpass $1.2 billion by 2031.
Analysts at Cantor Fitzgerald have noted the growing prevalence of allergies and the positive reception among allergy specialists, some of whom have expressed concerns about neffy's effectiveness compared to injections during severe reactions.
Despite these reservations, there's optimism about the product's ability to fulfill unmet needs, with around 3.3 million patients having delayed or refused traditional treatment options.
ARS Pharmaceuticals has raised significant funding, over $280 million, positioning the company for aggressive expansion and commercialization of its new nasal spray.
With scientific and medical innovations proceeded by the region's renowned research institutions, San Diego continues to affirm its stature as a hub for biotech innovation.
The excitement surrounding neffy encapsulates hope for patients who have had limited alternatives for managing their severe allergies.
