FDA Approves First Nasal Spray for Allergic Reactions
The U.S. FDA has approved the first-ever nasal spray designed to treat severe allergic reactions, including anaphylaxis. ARS Pharmaceuticals received the approval for their product - Neffy - the first epinephrine nasal spray that provides a needle-free alternative to traditional epinephrine injections, making it easier and quicker for patients to manage severe allergic reactions.
ARS Pharmaceuticals, Inc, a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced that the U.S. Food and Drug Administration (FDA) approved neffy® (epinephrine nasal spray) 2 mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions.
“Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option – an often painful and anxiety-inducing needle injection of epinephrine. 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,” said Thomas B. Casale, M.D., Professor of Medicine and Pediatrics and Chief of Clinical and Translational Research in the USF Health Morsani College of Medicine's Division of Allergy and Immunology at the University of South Florida in Tampa, Florida. “FDA approval of neffy 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.”
Type I allergic reactions, including those caused by food, medications, and insect bites, can lead to life-threatening anaphylaxis and result in an estimated 500,000 emergency room (ER) visits each year, with nearly 60% of such patients reported to not have received epinephrine prior to visiting the ER.
“This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies – a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” said Richard Lowenthal, Co-Founder, President and Chief Executive Officer, ARS Pharmaceuticals. “Epinephrine treatment is only effective if available, readily usable, and administered appropriately. Our team has worked tirelessly to create an easy-to-carry, easy-to-use, needle-free device that offers peace of mind to patients and caregivers by enabling them to administer epinephrine quickly and confidently when needed. We thank the FDA staff for their partnership and support in the development of neffy, and are deeply grateful to the severe allergy community, including advocates, patients, parents, and healthcare professionals, for their contributions to the development of neffy as an important, life-saving treatment.”
The approval of neffy is based on data from five primary registration studies with a 2 mg intranasal dose of epinephrine. These primary clinical trials were supported by numerous pilot and supportive studies. neffy met all defined clinical endpoints and its pharmacokinetic (PK) and pharmacodynamic (PD) data were within the range of approved epinephrine injection products. These data included single- and twice-dosed studies in healthy adults, with self-administration and caregiver administration in Type I allergy patients, in pediatric patients ≥30 kg (66 lbs.) as well as in those with allergic rhinitis (congestion and runny nose). Adverse events in neffy clinical trials were generally mild in nature without any meaningful nasal irritation or pain, and no serious adverse events were reported in any clinical study.
“Anyone who has experienced or witnessed an anaphylaxis reaction knows it can be very stressful deciding when to inject epinephrine to themselves or a child and often delay,” said Dr. Jonathan Spergel, Chief of the Allergy Program at Children's Hospital of Philadelphia. “We know that earlier administration is better, and for many, the needle is a barrier that causes dangerous hesitation. That is why the field has long pursued an effective treatment approach that does not require an injection.”
Prioritizing Patient Access
As part of its commitment to access and affordability for all patients who need neffy, ARS Pharma plans to offer robust programs to support patient access. For people with severe allergic reactions who have commercial insurance that covers neffy, ARS Pharma is committed to limiting what most commercially insured patients pay to just $25 for each filled prescription of two single-use neffy devices via a co-pay savings program. For eligible patients without insurance coverage, situations in which a health plan does not yet cover neffy, or if a patient faces high out-of-pocket costs due to a high-deductible plan, ARS Pharma will offer a cash price of $199 for two doses of neffy via BlinkRx, a digital pharmacy service that is available to patients at no added cost. This cash price is also available for patients who use retail pharmacies via GoodRx, a free-to-use website and mobile app, or whose insurance plans explicitly carve out coverage of neffy. In addition, for eligible U.S. residents who are uninsured or underinsured, meet certain eligibility criteria, and have exhausted all other options, the ARS Pharma Patient Assistance Program (PAP) will provide neffy at no cost.
According to Dr. Lou Garrison, Professor Emeritus in The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute in the School of Pharmacy at the University of Washington, “neffy’s value to society should be measured by more than its benefit to the individual at the moment they use it to stop an anaphylactic reaction; its value is also in the reassurance it offers to everyone from just carrying it, knowing it can protect them in an emergency. Like a fire extinguisher in the home, neffy offers peace of mind to the person carrying it and also to their family and friends, who are reassured that the health of a loved one is better protected. But the peace of mind for potential patients and the similar spillover to their caregivers are values that are too often overlooked in health economics analyses. A product like neffy offers substantial societal value that should be embraced by insurance plans aligning care and coverage for patients affected by severe allergic reactions.”
“We join other patient organizations in our enthusiasm for the significant clinical and societal value of neffy, as well as ARS Pharma’s commitment to making it accessible for everyone no matter their insurance coverage,” said Peter Rubin, Executive Director of No Patient Left Behind, a non-profit dedicated to healthcare reforms that ensure patients can access the medicines of today and tomorrow. “Patients should not have to go without treatment due to out-of-pocket costs and ARS Pharma’s co-pay assistance program will help with that. This FDA approval is groundbreaking for patients living with severe allergies because neffy offers a clear benefit as an effective, convenient nasal spray. Ultimately, it is beneficial for all insurers and employer plan sponsors to cover neffy with affordable co-pays so that patients in need can access this needle-free epinephrine alternative when appropriately prescribed. Until then, we appreciate ARS Pharma for offering comprehensive programs to broaden patient access.”
Patient Support Available Through neffyconnect
To help ensure affordability and access, the neffyconnect program provides patients, caregivers, and healthcare professionals (HCPs) with information about patient support programs, such as medication fulfillment services and financial support to guide their treatment journey, including navigating insurance requirements and potential barriers to access. neffyconnect will also provide families with helpful educational resources and tools. ARS Pharma expects the majority of payors to formalize their coverage decision policies during the next six months; in the interim, neffyconnect can help HCPs and patients access financial support and medication fulfillment services. For more information, visit www.neffy.com or call 1-877-myneffy (1-877-696-3339).
“We commend the FDA's decision to approve ARS Pharma’s neffy, which offers the food allergy community a nasal-spray epinephrine delivery device,” said Sung Poblete, Ph.D., RN, CEO of FARE. “This needle-free breakthrough should make it easier for food allergy patients and those around them to administer epinephrine in the event of an anaphylactic reaction. Importantly, we believe that innovation of this nature should also make it easier to have epinephrine more broadly available for use in the event of an emergency—in police cruisers, at restaurants, in airplanes, at hotels, at amusement parks, and in other areas where accidental exposures are possible. This is a win for the food allergy community.”
“Studies show adults and teens with food allergies often don’t carry their auto-injectors. This new technology may overcome the inherent reluctance of people to carry bulkier epinephrine with them everywhere,” said Lianne Mandelbaum, an advocate for people with food allergies and Founder of the non-profit No Nut Traveler. “Currently the FAA only requires planes to include vials of epinephrine, which have to be administered with syringes. This can take time, and time is of the essence when treating an allergic reaction for the best possible outcome. This becomes critical in the air where backup medical care is not accessible. A small, convenient needle-free device may not only be vital to those who carry it but extend a safety net to fellow passengers who are not otherwise prepared for a mile-high allergic reaction.”
Product Availability
neffy is expected to be available in the United States within eight weeks of FDA approval for patients who weigh 30 kg or greater (66 lbs.). In the interim, patients can visit www.neffy.com to register for product updates, including when telemedicine services will be available. ARS Pharma plans to file a supplemental NDA application with the FDA for neffy (epinephrine nasal spray) for children who weigh 15 to <30 kg by the end of the third quarter of 2024. In the European Union (EU), neffy received a positive opinion and recommendation for approval from the Committee for Medicinal Products for Human Use on June 27, 2024, with commercial launch in the EU expected in Q4 2024 following the expected grant of market authorization by the European Commission (EC).
The shelf life of neffy is 30 months and allows for temperature exposure up to 122°F (50°C), making it a potentially effective treatment if left in a car or outside for a length of time. If accidentally frozen, neffy can be thawed and administered.
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