ARS Pharmaceuticals Announces Planned Launch of neffyinSchools Program to Provide Life-Saving Needle Free Epinephrine to Eligible K-12 Schools at No Cost
ARS Pharmaceuticals (Nasdaq: SPRY) announced the launch of neffyinSchools Program in January 2025, providing eligible K-12 schools with free neffy® (epinephrine nasal spray) for emergency allergic reaction treatment. Schools will receive two cartons (four doses) of neffy® 2mg, with free replacements upon use or expiration.
The program addresses critical needs as studies show up to 18% of children with food allergies experience reactions at school, and 25% of severe reactions occur in children with no previous allergy diagnosis. neffy® offers a needle-free alternative with a 30-month shelf life, making it safer for school staff to administer.
Schools must verify state legislation compliance for epinephrine stocking and indemnification laws before participation. Currently, 49 states and Washington DC allow schools to stock epinephrine, though specific regulations may vary by state.
ARS Pharmaceuticals (Nasdaq: SPRY) ha annunciato il lancio del programma neffyinSchools a gennaio 2025, fornendo a scuole K-12 idonee neffy® (spray nasale di epinefrina) gratuite per il trattamento delle reazioni allergiche d'emergenza. Le scuole riceveranno due cartoni (quattro dosi) di neffy® 2mg, con sostituzioni gratuite al momento dell'uso o della scadenza.
Il programma risponde a esigenze critiche poiché studi mostrano che fino al 18% dei bambini con allergie alimentari sperimenta reazioni a scuola, e il 25% delle reazioni severe si verifica in bambini senza precedente diagnosi di allergia. neffy® offre un'alternativa senza ago con una durata di conservazione di 30 mesi, rendendolo più sicuro per il personale scolastico somministrarlo.
Le scuole devono verificare la conformità alla legislazione statale per la scorta di epinefrina e le leggi di indennità prima di partecipare. Attualmente, 49 stati e Washington DC consentono alle scuole di accumulare epinefrina, anche se le normative specifiche possono variare da stato a stato.
ARS Pharmaceuticals (Nasdaq: SPRY) anunció el lanzamiento del programa neffyinSchools en enero de 2025, proporcionando a las escuelas K-12 elegibles neffy® (spray nasal de epinefrina) gratuito para el tratamiento de reacciones alérgicas de emergencia. Las escuelas recibirán dos cartones (cuatro dosis) de neffy® 2mg, con reemplazos gratuitos al momento de uso o expiración.
El programa aborda necesidades críticas, ya que estudios muestran que hasta el 18% de los niños con alergias alimentarias experimentan reacciones en la escuela, y el 25% de las reacciones severas ocurren en niños sin un diagnóstico previo de alergia. neffy® ofrece una alternativa sin aguja con una vida útil de 30 meses, lo que la hace más segura para que el personal escolar la administre.
Las escuelas deben verificar la conformidad con la legislación estatal para el almacenamiento de epinefrina y las leyes de indemnización antes de participar. Actualmente, 49 estados y Washington DC permiten que las escuelas almacenen epinefrina, aunque las regulaciones específicas pueden variar según el estado.
ARS Pharmaceuticals (Nasdaq: SPRY)는 2025년 1월에 neffyinSchools 프로그램을 시작한다고 발표했으며, K-12 학교에 무료로 neffy®(에피네프린 비강 스프레이)를 제공하여 응급 알레르기 반응 치료를 지원합니다. 학교는 neffy® 2mg 두 상자(네 용량)를 받게 되며, 사용 또는 만료 시 무료로 교체해드립니다.
이 프로그램은 18%의 식품 알레르기가 있는 어린이가 학교에서 반응을 경험하고, 25%의 심각한 반응이 이전 알레르기 진단이 없는 어린이에게 발생한다는 연구 결과를 감안하여 중요한 요구를 해결합니다. neffy®는 30개월의 유통 기한을 가지고 있어, 학교 직원이 안전하게 수여할 수 있는 주사기 없는 대안을 제공합니다.
학교는 참여하기 전에 에피네프린 비축 및 인디인치 관계 법규에 대한 주법 준수를 확인해야 합니다. 현재 49개 주와 워싱턴 DC에서는 학교가 에피네프린을 비축할 수 있도록 허용하지만, 특정 규정은 주마다 다를 수 있습니다.
ARS Pharmaceuticals (Nasdaq: SPRY) a annoncé le lancement du programme neffyinSchools en janvier 2025, fournissant à des écoles K-12 éligibles des neffy® (spray nasal d’épinéphrine) gratuits pour traiter les réactions allergiques d’urgence. Les écoles recevront deux cartons (quatre doses) de neffy® 2mg, avec des remplacements gratuits lors de l'utilisation ou de l'expiration.
Le programme répond à des besoins critiques, car des études montrent qu’un enfant sur six souffrant d'allergies alimentaires a des réactions à l'école, et 25 % des réactions sévères se produisent chez des enfants n’ayant pas de diagnostic d’allergie préalable. neffy® offre une alternative sans aiguille avec une durée de conservation de 30 mois, ce qui le rend plus sûr pour le personnel scolaire à administrer.
Les écoles doivent vérifier la conformité aux lois étatiques concernant le stockage d'épinéphrine et les lois d’indemnisation avant de participer. Actuellement, 49 États et Washington DC permettent aux écoles de stocker de l’épinéphrine, bien que les réglementations spécifiques puissent varier selon les États.
ARS Pharmaceuticals (Nasdaq: SPRY) gab die Einführung des neffyinSchools-Programms im Januar 2025 bekannt, das berechtigten K-12-Schulen kostenlose neffy® (Epinephrin-Nasenspray) für die Notfallbehandlung von allergischen Reaktionen zur Verfügung stellt. Schulen erhalten zwei Kartons (vier Dosen) von neffy® 2mg, mit kostenlosen Ersatzlieferungen nach Gebrauch oder Ablauf.
Das Programm reagiert auf kritische Bedürfnisse, da Studien zeigen, dass bis zu 18% der Kinder mit Lebensmittelallergien in der Schule Reaktionen erleben und 25% der schweren Reaktionen bei Kindern ohne vorherige Allergiediagnose auftreten. neffy® bietet eine nadelfreie Alternative mit einer Haltbarkeit von 30 Monaten, was es für das Schulpersonal sicherer macht, es zu verabreichen.
Schulen müssen vor der Teilnahme die Einhaltung der staatlichen Gesetze zum Lagern von Epinephrin und zu den Indemnitätsgesetzen überprüfen. Derzeit erlauben 49 Bundesstaaten und Washington D.C. Schulen, Epinephrin zu lagern, obwohl spezifische Vorschriften je nach Bundesstaat variieren können.
- Product recently received FDA approval for Type I Allergic Reactions treatment
- Program provides free product to schools, potentially expanding market presence
- Long shelf life of 30 months compared to alternatives
- Addresses a significant market need with 18% of allergic children experiencing reactions at school
- State legislation may limit product adoption in some regions
- Program costs could impact company financials (free product distribution)
Insights
The neffyinSchools program represents a significant strategic initiative with potential positive business implications. The program targets a critical market segment, as studies show
The 30-month shelf life of neffy provides a competitive advantage over traditional auto-injectors. By offering free initial doses to schools, ARS Pharmaceuticals is implementing a smart market penetration strategy that could lead to sustained future sales through replacement orders and broader adoption. The timing aligns well with the recent FDA approval, potentially accelerating market acceptance and establishing neffy as the standard emergency epinephrine treatment in educational settings.
The program's launch in 49 states plus DC provides extensive market coverage, though state-specific legislation may impact initial adoption rates. This strategic initiative could significantly boost brand recognition and market share in the
The program demonstrates strong commercial potential through several key aspects. First, it creates a direct pathway to a large, captive market of K-12 schools across the U.S. The no-cost initial distribution strategy reduces barriers to entry and could accelerate adoption rates significantly. Schools requiring replacement doses after use or expiration represent a reliable revenue stream.
The needle-free administration addresses a important market pain point - needle phobia - while offering practical advantages for school staff in terms of safety and disposal. This differentiation from traditional auto-injectors could drive preference among school administrators and healthcare staff. The extensive state coverage and timing of the launch (January 2025) allows for proper market preparation and regulatory alignment.
This initiative positions ARS Pharmaceuticals favorably in the competitive landscape, potentially leading to increased market penetration and sustained revenue growth through both institutional and consumer channels.
Qualifying public and private K-12 Schools in the U.S. will be eligible to receive two free cartons (four single use doses) of neffy® (epinephrine nasal spray) 2mg for use in emergency treatment of allergic reactions including anaphylaxis
Interested schools are encouraged to review applicable state laws and regulations to ensure neffy for undesignated use meets all requirements
SAN DIEGO, Dec. 04, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that it will be launching the neffyinSchools Program in January 2025. The program will provide eligible public and private K-12 schools in the U.S. the opportunity to receive two cartons (four single use doses) of neffy® (epinephrine nasal spray) 2mg for use in emergency situations at no cost to the school. neffy 2mg was recently approved for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.) Participating schools will be eligible to receive replacement doses when the product is used or expires.
Type 1 allergic reactions can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, foods, medication, exercise, or other unknown causes. Studies show that up to
“The potential for severe allergic reactions to food, medication, exercise or insect bites can quickly result in an emergency if epinephrine is not available. Since many unexpected allergic reactions happen during the school day, readily available epinephrine is crucial,” says Richard Lowenthal, Co-Founder, President and CEO of ARS Pharmaceuticals. “Additionally, many people, including students, have a fear of needles which could impact, delay or prevent the use of an auto-injector. We are committed to making neffy, the only needle-free epinephrine treatment option, available free of charge to all eligible schools through our neffyinSchools program because we know neffy will save lives. We also understand that there are currently many challenges for schools that stock epinephrine. neffy is safer for school staff when administering epinephrine in allergy emergency situations, is easier to dispose as neffy doesn’t contain any sharps, and it has a long shelf life of 30 months.”
In advance of the neffyinSchools launch, schools are encouraged to review applicable state legislation to ensure neffy meets the requirements of local epinephrine stocking and indemnification laws for undesignated use. Currently, 49 states and Washington DC have legislation in place to allow schools to stock epinephrine. The details of each state’s legislation, and ability to stock neffy specifically, may vary. For states that do not yet allow for neffy because stocking protocols have not been updated to reflect this product and/or route of administration, school administrators may need to contact their state legislator to request modifications to state legislation to ensure school personnel are indemnified from liability for use of FDA approved epinephrine products. Many patient advocacy groups have information and resources on this topic that can be found here.
A webinar will be hosted on December 12 to provide information to school nurses and adminstrators about the neffyinSchools program, general information about neffy as well as training and other online resources. Following the program’s official launch in January 2025, ARS Pharma will provide application instructions to schools to receive neffy 2mg.
More information about this program can be found at www.ars-pharma.com and www.neffy.com under the Community Program tab. Additional updates will be provided on ARS LinkedIn and X pages. The neffyinSchools program is subject to the more detailed terms and conditions which will be available on the Company’s website prior to the official launch of the neffyinSchools program.
About neffyinSchools
ARS is committed to working with our communities to provide essential epinephrine in schools. Eligible public and private K-12 schools in the U.S. (excluding territories) will be able to receive two cartons (four single use doses) of neffy 2mg for adults and children who weigh ≥30 kg (66 lbs.), in emergency situations. The neffyinSchools program is only for undesignated use, and children with prescriptions for epinephrine from their healthcare provider must continue to supply medication to their school in accordance with school guidelines. Schools must review applicable state legislation to ensure neffy meets the requirements of local epinephrine stocking and administration laws for undesignated use. The supplemental NDA for neffy 1mg dose was granted priority review by the FDA and has a PDUFA date set for March 6, 2025. If approved, neffy 1mg will be available to schools for students who weigh between 33 and 66 lbs. The neffyinSchools program is subject to the more detailed terms and conditions which will be available on the Company’s website prior to the official launch of the neffyinSchools program
About neffy®
neffy is an intranasal epinephrine product for patients with Type I allergic reactions including food, medications, and insect bites that could lead to life-threatening anaphylaxis.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy 2 mg is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater.
IMPORTANT SAFETY INFORMATION
It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose.
neffy is for use in the nose only.
Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.
Absorption of neffy may be affected by underlying structural or anatomical nasal conditions.
Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.
The presence of a sulfite in neffy should not deter use.
neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy.
Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions.
Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.
Adverse reactions to neffy may include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.
These are not all of the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional information on neffy, please see Full Prescribing Information at www.neffy.com.
About Type I Allergic Reactions Including Anaphylaxis
Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency.
About ARS Pharmaceuticals, Inc.
ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® 2 mg (trade name EURneffy® in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com.
Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the expected timing and launch of neffyinSchools; the needle-free profile of neffy and making neffy available at no cost to eligible public and private K-12 schools increasing the likelihood that such schools will both carry and administer adrenaline to students experiencing an allergic reaction; the expectation that neffy will save lives; the potential for stocking neffy to qualify under indemnification laws for undesignated use; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “expects,” “if,” “may,” “potential,” “on track to,” “plans,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from neffy; ARS Pharmaceuticals may not receive the anticipated benefits from the neffyinSchools program; public and private schools may be participate in the neffyinSchools program to the degree or on the timelines expected by ARS Pharmaceuticals the scope, progress and expansion of developing and commercializing neffy; the potential for payors to delay, limit or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharmaceuticals’ ability to protect its intellectual property position; the impact of government laws and regulations; and the PDUFA target action date may be delayed due to various factors outside ARS Pharmaceuticals’ control. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024. These documents can also be accessed on ARS Pharmaceuticals’ website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.
The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharmaceuticals assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
ARS Investor Contact:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com
ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com
1 Centers for Disease Control and Prevention. Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs. Washington, DC: US Department of Health and Human Services; 2013.
FAQ
When will ARS Pharmaceuticals (SPRY) launch the neffyinSchools Program?
How many neffy doses will schools receive through the SPRY neffyinSchools Program?
What is the shelf life of neffy nasal spray from ARS Pharmaceuticals (SPRY)?
How many states currently allow schools to stock epinephrine for SPRY's neffyinSchools Program?
