FDA Approves ARS Pharmaceuticals' Lower Dose Neffy Nasal Spray For Emergency Allergy Treatment

On Wednesday, the FDA approved ARS Pharmaceuticals, Inc.’s SPRY neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms.

The approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years.

Approval of neffy 1 mg follows FDA approval for neffy 2 mg for children and adults weighing 30kg and for EURneffy in the EU by the European Commission in August 2024.

The approval of neffy 1 mg is based on data from clinical trials, including pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and adult subjects consistent with those of epinephrine injection products.

Adverse events in pediatric trials were generally mild and transient.

The device has a shelf-life of 24 months at room temperature and tolerance to temperature exposures up to 122°F (50°C) based on testing for up to 3 months. If accidentally frozen, it can be thawed without impacting the product’s quality and reliability.

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Most commercially insured patients will pay no more than $25 for two single-use neffy devices through a co-pay savings program.

If the product isn’t covered by insurance, the cash price of $199 for two doses is available through BlinkRx and coupon can be downloaded from GoodRx for use at local retail pharmacies.

For certain uninsured or underinsured U.S. residents meeting eligibility criteria and exhausted all other options, the ARS Pharma Patient Assistance Program will provide neffy at no cost.

William Blair analyst Lachlan Hanbury-Brown writes, “While the approval was largely expected, we believe it nonetheless represents an important milestone for the company as it advances the launch of neffy 2 mg.”

The analyst noted that although Neffy 1 mg accounts for only about 15% of the epinephrine market by volume, the company’s research shows that needle phobia is most common in children.

Many caregivers are also hesitant to use needle-based autoinjectors on their children, which could drive higher adoption of neffy among pediatric patients.

In the U.S., nearly 40% of epinephrine prescriptions are for children. Since its September launch, about two-thirds of Neffy 2 mg prescriptions have been for children, indicating strong early adoption in this group.

Price Action: SPRY stock is down 1.29% at $10.73 during the premarket session at the last check Thursday.

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