Newly Approved ARS Pharmaceuticals' Needle-Free Neffy Offers Convenience Over EpiPen For Allergic Reaction, But Real-World Efficacy Questioned

Earlier this month, the FDA approved ARS Pharmaceuticals Inc’s SPRY Neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), for adult and pediatric patients.

The nasal spray version of epinephrine is poised to enter the market as an alternative to auto-injectors like the EpiPen for treating severe allergic reactions.

Also Read: ARS Pharma Readies Data In Response To FDA’s Rejection For Its EpiPen Alternative For Severe Allergic Reactions.

While Neffy’s needle-free application offers a more convenient and potentially less painful option, some allergists are hesitant to prescribe it until further studies confirm its effectiveness during actual anaphylactic emergencies.

According to a pediatric allergist at UT Southwestern and director of the Food Allergy Center at Children’s Medical Center in Dallas, Neffy could be particularly beneficial for adults hesitant to self-inject and parents uneasy about injecting their children.

Neffy’s small size—roughly half the size of an iPhone—also makes it easier to carry, potentially boosting compliance among high-risk patients.

A 2023 study found that only about 40% of those at high risk consistently carry their auto-injectors, citing inconvenience and a false sense of security as primary reasons.

The NPR report adds that ARS Pharmaceuticals took over eight years to develop Neffy. It offers several advantages over auto-injectors like the EpiPen.

Its shelf life extends to two years, compared to the typical 12-18 months for auto-injectors, and it can withstand temperature fluctuations, unlike EpiPens, which must be stored at room temperature.

The report notes that Neffy could become the preferred option in public settings like schools and airplanes due to its ease of storage and use.

However, some physicians remain cautious, as they highlight that Neffy has not been tested in patients experiencing real-time anaphylactic reactions, raising concerns about its efficacy.

Nasal congestion during an allergic reaction could block the drug’s absorption, potentially worsening the reaction.

Insurance coverage is another uncertainty. ARS is working with insurers to get Neffy approved, a process that could take up to six months.

The spray is expected to be priced similarly to auto-injectors, with a two-pack estimated to cost around $150-$200, depending on insurance coverage.

Despite these developments, some doctors plan to delay prescribing Neffy initially, citing the administrative burden of navigating insurance coverage for a new drug.

Price Action: SPRY stock is up 2.89% at $13.18 at last check Friday.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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Photo via ARS Pharmaceuticals