Neffy Epinephrine Spray Now Available for Preorder

ARS Pharmaceuticals has launched preordering services for neffy epinephrine nasal spray for quick access to patients upon its expected availability in late September.¹

“People with severe allergies have been waiting for a needle-free epinephrine option, which is why we have prioritized a number of support programs, including the launch of today’s pre-ordering service,” Richard Lowenthal, cofounder, President and CEO of ARS Pharmaceuticals said in a statement.¹ “Now, patients can work with their healthcare provider or have a virtual consultation with a physician to obtain a prescription for neffy and get it shipped directly to their homes in as little as 2 days following availability in the US. One major advantage of ordering through neffy.com, for patients and healthcare providers, is that ARS Pharmaceuticals will be able to help with prior authorization from insurance companies, so many patients could have a co-pay as low as $25 for two single-use neffy devices.”

Preordering can begin immediately via neffy.com. Patients can obtain a prescription through their existing healthcare provider or through requesting a virtual consultation on the site. The neffyConnect service BlinkRx is accepting prescriptions for neffy now, which will be shipped when available. The service can also guide patients to insurance support and affordable pricing options, including a copay of $25 for commercially insured patients, an out-of-pocket cost of $199, and a no-cost Patient Assistance Program (PAP) for eligible patients, for 2 doses of neffy.¹

"From the perspective of someone who is both a clinician and a food allergy patient, having another option for epinephrine delivery is crucial. Quick administration of epinephrine is key to managing anaphylaxis and reducing injection hesitancy plays an essential role in ensuring timely treatment. We’re pleased that patients will soon be able to access another option for their epinephrine delivery," Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research and Education), added.¹

The FDA approved neffy for the emergency treatment of severe allergic reactions, such as life-threatening anaphylaxis, in adults and children over 30 kg (66 lbs) in August 2024.² The approval marked the first alternative option to injectable epinephrine, in the form of such products as the EpiPen. The spray is administered in a single-dose into 1 nostril, though a second dose may be administered in the same nostril if symptoms do not improve.

The approval of neffy was supported by 4 clinical trials evaluating a total of 175 healthy adult subjects. The studies confirmed similar concentrations of epinephrine in the blood of these subjects following administration of the nasal spray and other current injectable epinephrine products. Comparable increases in subjects’ blood pressure and heart rates were also noted—2 key impacts of epinephrine in treating anaphylaxis.²

Among children weighing more than 66 pounds, the epinephrine levels achieved with the nasal spray in 1 study were shown to be similar to those seen among adult patients. Though the spray may be easily implemented, the FDA announcement notes that patients may still require emergency medical care for the purposes of monitoring the anaphylactic episode.²

“I do think that this has the potential to really dramatically change the landscape,” Edwin H. Kim, MD, associate professor of pediatrics at University of North Carolina’s School of Medicine, told HCPLive after the approval. “I think we have always known in the allergy field that epinephrine works. Epinephrine is able to stop allergic reactions, prevent anaphylaxis, and keep people safe. But we've also run into many situations where epinephrine is not administered, and for many reasons but one of the biggest ones is just fear and anxiety around the injection aspect.”

The FDA previously chose not to approve neffy in September 2023, instead issuing a complete response letter requesting a new pharmacokinetic/pharmacodynamic study in which repeat doses of neffy would be compared to an injection product under allergen-induced allergic rhinitis conditions.³

“We've had many stories where folks are thinking about holding on to the EpiPen, thinking ‘Should I use this? Should I not?’ and those kinds of delays sometimes can lead to bigger reactions,” Kim said. “So hopefully with a non-injection form of this, folks will be much more willing and open to not only use it but use it early on in a reaction to prevent these reactions from becoming more severe.”

REFERENCES
1. ARS Pharmaceuticals Launches Pre-Ordering Services for neffy® to Help Patients Access the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis. News release. ARS Pharmaceuticals. September 4, 2024. https://www.globenewswire.com/news-release/2024/09/04/2940455/0/en/ARS-Pharmaceuticals-Launches-Pre-Ordering-Services-for-neffy-to-Help-Patients-Access-the-First-and-Only-Needle-Free-Treatment-for-Type-I-Allergic-Reactions-Including-Anaphylaxis.html
2. Office of the Commissioner. FDA approves first nasal spray for treatment of anaphylaxis. U.S. Food and Drug Administration. August 9, 2024. Accessed August 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis.
3. FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study. GlobeNewswire. September 20, 2023. https://www.globenewswire.com/news-release/2023/09/20/2746095/0/en/FDA-Issues-Complete-Response-Letter-for-neffy-epinephrine-nasal-spray-New-Drug-Application-with-Request-for-Additional-Study.html. Date accessed: September 20, 2023.