Thomas Casale, MD | Image credit: USF Health

Pre-ordering epinephrine nasal spray

Pre-ordering for epinephrine nasal spray (neffy; ARS Pharmaceuticals) to treat type 1 of allergic reactions, including anaphylaxis, in adult and pediatric patients who weight at least 66 pounds (30 kilograms) has launched.^1,2

According to ARS, pre-ordering can begin immediately at neffy.com.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,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharmaceuticals.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 [United States]. 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 [2] single-use neffy devices," said Lowenthal.¹

Providers can use the neffyConnect service and the BlinkRx online pharmacy, which are already accepting prescriptions for neffy, according to ARS. Patients will be shipped neffy free of charge via BlinkRx.¹

"Quick administration of epinephrine is key to managing anaphylaxis and reducing injection hesitancy plays an essential role in ensuring timely treatment," said Sung Poblete, PhD, RN, CEO of Food Allergy Research and Education, in a statement. "We’re pleased that patients will soon be able to access another option for their epinephrine delivery."¹

FDA approval

The nasal spray was approved by the FDA on August 9, 2024, and was based on comparable epinephrine blood concentration data following administration of neffy or approved epinephrine injection products demonstrated in 4 studies comprising 175 healthy adults without anaphylaxis.²

"We know that a lot of patients are reluctant to either inject themselves or inject their children with epinephrine because of needle phobia," said Thomas Casale, MD, professor of medicine, chief of Clinical and Translational Research, Allergy and Immunology, University of South Florida, in a previous interview with Contemporary Pediatrics. "Having alternatives is very important."²

The approval came nearly a year after a Complete Response Letter (CRL) was issued by the FDA on September 19, 2023, requesting the completion of a pharmacokinetic/pharmacodynamic study to assess repeat doses of neffy compared to repeat doses of an epinephrine injector.²

In May 2023, the FDA's Pulmonary-Allergy Drug Advisory Committee (PADAC) voted in support of a favorable benefit-risk profile for neffy in May 2023. The PADAC voted 16 to 6 in favor for adults and 17 to 5 in favor for children under 18 years weighing over 66 lbs.²

Pharmacokinetic profile compared to injection

In response to the CRL, ARS reported topline data for repeat doses of neffy compared to repeat doses of epinephrine intramuscular (IM) injections with and without nasal allergen challenge (NAC). In a previous Q+A interview published on Contemporary Pediatrics in Feburary 2024, Sarina Tanimoto, MD, MBA, chief medical officer, ARS Pharma, broke down the study design and highlighted results:²

Sarina Tanimoto, MD, MBA:

"EPI 10 included a total of 80 doses of neffy. Twelve [individuals] with body weight 15-30 kg received 0.65 mg neffy and 21 [individuals] with body weight 15-30 kg received 1 mg neffy. In the higher weight group of 30 kg or greater, 26 subjects received a 1 mg dose of neffy and 21 subjects received a 2 mg dose of neffy.²

The data presented in this poster from the study included a total of 42 pediatric [individuals] that received the commercial doses of neffy which will be 1 mg for children 15 to <30 kg and 2 mg for children 30 kg or greater.²

Half the [individuals] (n = 21) were 15-30 kg in weight, while the other half (n = 21) were 30kg+ in weight. Age range of subjects in the study is 4 to 17 years.²

Separately from this EPI-10 study, to compare these data to injection, integrated PK analyses, including pharmacological base absorption model (PBAM) and a population pharmacokinetics assessments (POP PK) model were also used to extrapolate results from 0.3 mg IM injection and 0.3 mg EpiPen in our adult studies to pediatric subjects. These analyses demonstrated that neffy achieved exposures in pediatrics that are comparable to or slightly greater than that observed with injection in adults."²

Click here for the full Q+A interview.

“Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option – an often painful and anxiety-inducing needle injection of epinephrine," Casale said regarding the FDA's decision. "In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment. [This approval] means that patients with severe allergies finally gain a long-awaited, needle-free, easy-to-carry epinephrine delivery method that has the potential to reduce time to administration, which can lead to better clinical outcomes and improvements in quality of life for patients and their caregivers.”²

References:

1. ARS Pharmaceuticals launches pre-ordering services for neffy to help patients access the first and only needle-free treatment for type 1 allergic reactions, including anaphylaxis. ARS Pharmaceuticals. Press release. September 4, 2024. Accessed September 4, 2024. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-launches-pre-ordering-services-neffyr-help
2. Fitch, J. FDA approves neffy as first nasal spray to treat anaphylaxis. Contemporary Pediatrics. August 9, 2024. Accessed September 4, 2024. https://www.contemporarypediatrics.com/view/fda-approves-neffy-as-first-nasal-spray-to-treat-anaphylaxis