ARS Pharmaceuticals Announces neffy® (Epinephrine Nasal Spray) is available on Express Scripts Commercial National Formularies
ARS Pharmaceuticals (SPRY) announced that Express Scripts has added neffy® (epinephrine nasal spray) to its Commercial national formularies, effective November 22, 2024. This inclusion makes neffy accessible to millions of commercially insured patients nationwide. neffy 2 mg, the first FDA-approved epinephrine nasal spray, treats Type I Allergic Reactions in adults and children weighing ≥30 kg.
The product features a needle-free design, 30-month shelf-life, and temperature tolerance up to 122°F. This represents the first new epinephrine delivery method in over 35 years. The formulary inclusion occurred just nine weeks after product introduction, demonstrating strong market acceptance. ARS Pharma expects additional payers to provide neffy access in the coming weeks and offers support programs for coverage and affordability.
ARS Pharmaceuticals (SPRY) ha annunciato che Express Scripts ha aggiunto neffy® (spray nasale di epinefrina) ai suoi formulari nazionali commerciali, a partire dal 22 novembre 2024. Questa inclusione rende neffy accessibile a milioni di pazienti coperti da assicurazione commerciale in tutto il paese. Neffy 2 mg, il primo spray nasale di epinefrina approvato dalla FDA, tratta le reazioni allergiche di Tipo I in adulti e bambini di peso ≥30 kg.
Il prodotto presenta un design senza ago, una durata di conservazione di 30 mesi e una tolleranza alla temperatura di fino a 122°F. Questa rappresenta il primo nuovo metodo di somministrazione di epinefrina in oltre 35 anni. L'inclusione nel formulario è avvenuta solo nove settimane dopo l'introduzione del prodotto, dimostrando una forte accettazione sul mercato. ARS Pharma si aspetta che ulteriori assicuratori offrano accesso a neffy nelle prossime settimane e offre programmi di supporto per la copertura e l'affordabilità.
ARS Pharmaceuticals (SPRY) anunció que Express Scripts ha añadido neffy® (espray nasal de epinefrina) a sus formularios nacionales comerciales, con efecto a partir del 22 de noviembre de 2024. Esta inclusión hace que neffy esté disponible para millones de pacientes asegurados comercialmente en todo el país. Neffy 2 mg, el primer espray nasal de epinefrina aprobado por la FDA, trata las reacciones alérgicas de Tipo I en adultos y niños que pesen ≥30 kg.
El producto presenta un diseño sin aguja, una vida útil de 30 meses y una tolerancia a temperaturas de hasta 122°F. Esto representa el primer nuevo método de entrega de epinefrina en más de 35 años. La inclusión en el formulario se produjo solo nueve semanas después de la introducción del producto, lo que demuestra una fuerte aceptación en el mercado. ARS Pharma espera que otros pagadores proporcionen acceso a neffy en las próximas semanas y ofrece programas de apoyo para la cobertura y la asequibilidad.
ARS Pharmaceuticals (SPRY)는 Express Scripts가 neffy® (에피네프린 비강 스프레이)를 2024년 11월 22일부터 상업용 국가 목록에 추가했다고 발표했습니다. 이 포함으로 인해 neffy는 전국적으로 수백만 명의 상업보험 가입자가 사용할 수 있게 됩니다. Neffy 2 mg는 FDA에서 승인된 최초의 에피네프린 비강 스프레이로, 성인 및 체중이 30 kg 이상인 어린이의 제1형 알레르기 반응을 치료합니다.
이 제품은 바늘이 없는 디자인, 30개월의 유통기한 및 122°F까지의 온도 허용 범위를 가지고 있습니다. 이는 35년 이상 만에 처음으로 새로운 에피네프린 투여 방법을 나타냅니다. 이 목록 추가는 제품 소개 후 단 9주 만에 이루어졌으며, 이는 시장에서의 강한 수용을 보여줍니다. ARS Pharma는 앞으로 몇 주 안에 추가 보험사들이 neffy에 대한 접근을 제공할 것으로 기대하고 있으며, 보장 및 경제성을 위한 지원 프로그램을 제공합니다.
ARS Pharmaceuticals (SPRY) a annoncé qu'Express Scripts a ajouté neffy® (spray nasal d'épinéphrine) à ses formulaires nationaux commerciaux, à compter du 22 novembre 2024. Cette inclusion rend neffy accessible à des millions de patients assurés commercialement à l'échelle nationale. Neffy 2 mg, le premier spray nasal d'épinéphrine approuvé par la FDA, traite les réactions allergiques de type I chez les adultes et les enfants pesant ≥30 kg.
Le produit présente une conception sans aiguille, une durée de conservation de 30 mois et une tolérance aux températures allant jusqu'à 122°F. Cela représente la première nouvelle méthode d'administration d'épinéphrine depuis plus de 35 ans. L'inclusion dans le formulaire est survenue seulement neuf semaines après l'introduction du produit, démontrant une forte acceptation sur le marché. ARS Pharma s'attend à ce que d'autres payeurs offrent un accès à neffy dans les semaines à venir et propose des programmes de soutien pour la couverture et l'accessibilité.
ARS Pharmaceuticals (SPRY) hat bekannt gegeben, dass Express Scripts neffy® (Epinephrin-Nasenspray) ab dem 22. November 2024 in seine nationalen Handelsformulare aufgenommen hat. Diese Aufnahme macht neffy für Millionen von kommerziell versicherten Patienten landesweit zugänglich. Neffy 2 mg, das erste von der FDA zugelassene Epinephrin-Nasenspray, behandelt Typ-I-Allergische Reaktionen bei Erwachsenen und Kindern mit einem Gewicht von ≥30 kg.
Das Produkt verfügt über ein nadelfreies Design, eine Haltbarkeit von 30 Monaten und eine Temperaturtoleranz von bis zu 122°F. Dies stellt die erste neue Methode zur Abgabe von Epinephrin seit über 35 Jahren dar. Die Aufnahme in das Formular erfolgte nur neun Wochen nach der Produkteinführung und zeigt eine starke Marktakzeptanz. ARS Pharma erwartet, dass in den kommenden Wochen weitere Leistungserbringer den Zugang zu neffy ermöglichen und bietet Unterstützungsprogramme für Deckung und Erschwinglichkeit an.
- First FDA-approved needle-free epinephrine nasal spray
- Rapid inclusion on Express Scripts Commercial National Formularies (9 weeks post-launch)
- Access to millions of commercially insured patients
- Superior product features: 30-month shelf-life, high temperature tolerance (122°F)
- to patients weighing ≥30 kg (66 lbs.)
- Currently dependent on individual payer coverage decisions
Insights
Express Scripts' inclusion of neffy® on its commercial formularies represents a major market access milestone for ARS Pharmaceuticals. With Express Scripts serving over 100 million Americans, this formulary addition significantly expands the potential patient reach for this innovative epinephrine delivery system.
The rapid nine-week timeline from launch to formulary inclusion is notably swift, indicating strong payer recognition of neffy's value proposition. This accelerated access pathway suggests favorable pricing negotiations and potential for strong market uptake. The timing positions ARS Pharmaceuticals well for the 2024 allergy season.
From a competitive standpoint, neffy's novel needle-free delivery system addresses a clear market gap in the
The Express Scripts formulary placement is strategically crucial, coming just ahead of typical January benefit resets. This timing maximizes neffy's commercial potential for 2024, as many patients reassess their medication choices at the start of new benefit years. The company's proactive patient support programs, including savings initiatives, demonstrate sophisticated market access planning.
For investors, this development substantially de-risks neffy's commercial launch. Express Scripts' rapid adoption could create momentum for other major payers to follow suit, potentially accelerating broader market access. The revenue potential is significant given that many current epinephrine auto-injector users may prefer a needle-free option, especially for children and needle-phobic patients.
Inclusion of neffy on Express Scripts commercial formularies was effective November 22, 2024 and expands access to patients and caregivers managing Type 1 Allergic Reactions
SAN DIEGO, Dec. 19, 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 Express Scripts, the pharmacy benefits business of Evernorth Health Services, has added neffy® (epinephrine nasal spray) to its Commercial national formularies. This decision makes neffy broadly available to millions of their commercially insured patients across the country.
neffy 2 mg is for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). It is the first and only FDA-approved epinephrine nasal spray that provides a needle-free alternative to traditional injectable epinephrine and the first new delivery method for epinephrine in more than 35 years. Its simple and intuitive design enables rapid administration, helping patients and caregivers act quickly and confidently, and the small size is easy to carry. Additionally, neffy has a shelf-life of 30 months and temperatures exclusions up to 122 degrees Fahrenheit.
“The inclusion of neffy on Express Scripts’ Commercial National Formularies significantly improves access to life-saving allergy treatment,” said Sal Grausso, Head of Market Access at ARS Pharma. “This highlights the importance of providing a user-friendly solution that empowers patients and caregivers to respond quickly and effectively to severe allergic reactions, demonstrating the value of neffy in addressing unmet medical needs in the allergy community. We’re also very pleased with the quick turnaround between product introduction and the inclusion of neffy on Express Scripts’ formularies in only nine weeks. We will be working diligently to ensure continued access for as many patients and caregivers as possible.”
This expanded access aligns with ARS Pharma’s commitment to reducing barriers to care and improving outcomes for patients who rely on epinephrine during allergy emergencies. ARS Pharma anticipates other payers to join Express Scripts in providing access to neffy in the coming weeks.
To support patients in navigating coverage and affordability challenges, ARS Pharma offers a number of programs for patients and caregivers. For more information, visit www.neffy.com/savings.
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 impact from the inclusion of neffy on Express Scripts’ Commercial National Formularies; ARS Pharmaceuticals’ expectation that ther payors will provide access to neffy and the timing by which they will provide such access; the needle-free profile of neffy increasing the likelihood that patients will both carry and administer adrenaline; the potential market and demand for neffy; 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; the labelling for neffy in any future indication or patient population, if approved; 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; and the impact of government laws and regulations. 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 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
FAQ
When did Express Scripts add SPRY's neffy to its commercial formularies?
What is the weight requirement for neffy nasal spray (SPRY)?
What is the shelf life of SPRY's neffy nasal spray?
How long did it take for Express Scripts to add SPRY's neffy to its formularies after launch?
What makes SPRY's neffy different from traditional epinephrine treatments?
