Editor’s Note: The story has been updated with the Phase 3 trial data in Japan and neffy’s pricing information.
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.
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.
The company conducted a Phase 3 study in Japanese pediatric patients (n=15) who experienced food allergies.
Data showed that no patient needed a second dose of epinephrine within 15 minutes post-dose, and neffy provided similar efficacy to existing epinephrine therapies. Most patients experience significant symptom relief within five minutes of administration.
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.
Since Mylan acquired U.S. rights to the EpiPen in 2007, its price has come under scrutiny due to a 600% increase, now retailing between $650 and $750 without insurance. The generic version ranges from $150 to $200 per GoodRx data.
ARS Pharma announced that most patients with commercial insurance covering Neffy can pay $25 for two single-use devices through a co-pay savings program.
For uninsured patients, those with plans not covering Neffy or those with high out-of-pocket costs, ARS Pharma offers a $199 cash price for two doses via BlinkRx, also available through GoodRx. Additionally, eligible uninsured or underinsured individuals in the U.S. can access Neffy for free through ARS Pharma’s Patient Assistance Program.
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 1.92% at $13.45 at the last check on Monday.
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
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