ARS Pharmaceuticals Announces U.S. Availability of neffy® (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
ARS Pharmaceuticals (Nasdaq: SPRY) announced that neffy® (epinephrine nasal spray) is now available by prescription across the U.S. for treating Type I Allergic Reactions, including anaphylaxis, in adults and children weighing ≥30 kg. The FDA approved neffy 2 mg last month, marking it as the first and only needle-free treatment for severe allergic reactions.
Through neffyConnect and BlinkRx, eligible commercially insured patients can obtain two single-use neffy devices for a $25 co-pay. Uninsured patients or those without coverage can access neffy for $199 for two devices. The company is also offering free carrying cases and has implemented various patient assistance programs to ensure accessibility.
ARS Pharmaceuticals plans to expand access to EURneffy® in Europe and has submitted an sNDA for neffy 1 mg use in pediatric patients weighing 15 to 30 kg.
ARS Pharmaceuticals (Nasdaq: SPRY) ha annunciato che neffy® (spray nasale di epinefrina) è ora disponibile su prescrizione negli Stati Uniti per il trattamento delle reazioni allergiche di tipo I, inclusa l'anafilassi, in adulti e bambini che pesano ≥30 kg. La FDA ha approvato neffy 2 mg il mese scorso, etichettandolo come il primo e unico trattamento senza ago per reazioni allergiche severe.
Attraverso neffyConnect e BlinkRx, i pazienti idonei con assicurazione commerciale possono ottenere due dispositivi neffy monouso con un co-pagamento di $25. I pazienti non assicurati o senza copertura possono accedere a neffy per $199 per due dispositivi. L'azienda offre anche custodie gratuite e ha implementato vari programmi di assistenza per i pazienti per garantire l'accessibilità.
ARS Pharmaceuticals prevede di espandere l'accesso a EURneffy® in Europa e ha presentato un sNDA per l'uso di neffy 1 mg in pazienti pediatrici che pesano tra 15 e 30 kg.
ARS Pharmaceuticals (Nasdaq: SPRY) anunció que neffy® (spray nasal de epinefrina) ya está disponible con receta en los EE. UU. para tratar reacciones alérgicas de tipo I, incluida la anafilaxis, en adultos y niños que pesen ≥30 kg. La FDA aprobó neffy 2 mg el mes pasado, marcándolo como el primer y único tratamiento sin aguja para reacciones alérgicas severas.
A través de neffyConnect y BlinkRx, los pacientes asegurados comercialmente elegibles pueden obtener dos dispositivos neffy de un solo uso con un co-pago de $25. Los pacientes sin seguro o aquellos sin cobertura pueden acceder a neffy por $199 por dos dispositivos. La empresa también ofrece estuches de transporte gratuitos y ha implementado varios programas de asistencia para pacientes para asegurar la accesibilidad.
ARS Pharmaceuticals planea expandir el acceso a EURneffy® en Europa y ha presentado un sNDA para el uso de neffy 1 mg en pacientes pediátricos que pesen entre 15 y 30 kg.
ARS 제약(나스닥: SPRY)은 neffy® (에피네프린 비강 스프레이)가 이제 처방전으로 미국 전역에서 30kg 이상 체중의 성인 및 아동의 제1형 알레르기 반응(아나필락시스 포함) 치료에 사용 가능하다고 발표했습니다. FDA는 지난달 neffy 2mg를 승인하여 중증 알레르기 반응에 대한 첫 번째이자 유일한 바늘 없는 치료제로 표시했습니다.
neffyConnect 및 BlinkRx를 통해 자격이 있는 상업적 보험 가입자는 $25의 공동 지불금으로 단일 사용을 위한 neffy 장치 두 개를 받을 수 있습니다. 보험이 없는 환자나 보험이 없는 환자는 두 장치에 대해 $199에 neffy를 이용할 수 있습니다. 이 회사는 무료 휴대 케이스를 제공하고 접근성을 보장하기 위해 다양한 환자 지원 프로그램을 시행했습니다.
ARS 제약은 유럽에서 EURneffy®의 접근성을 확장할 계획이며 15~30kg의 소아 환자에 대한 neffy 1mg 사용을 위한 sNDA를 제출했습니다.
ARS Pharmaceuticals (Nasdaq: SPRY) a annoncé que neffy® (spray nasal d'épinéphrine) est désormais disponible sur ordonnance aux États-Unis pour le traitement des réactions allergiques de type I, y compris l'anaphylaxie, chez les adultes et les enfants pesant ≥30 kg. La FDA a approuvé neffy 2 mg le mois dernier, le qualifiant de première et unique traitement sans aiguille pour les réactions allergiques sévères.
Grâce à neffyConnect et BlinkRx, les patients commerciaux admissibles peuvent obtenir deux dispositifs neffy à usage unique pour un co-paiement de 25 $. Les patients non assurés ou ceux sans couverture peuvent accéder à neffy pour 199 $ pour deux dispositifs. L'entreprise propose également des étuis de transport gratuits et a mis en place divers programmes d'assistance aux patients pour garantir l'accessibilité.
ARS Pharmaceuticals prévoit d'élargir l'accès à EURneffy® en Europe et a soumis une sNDA pour l'utilisation de neffy 1 mg chez les patients pédiatriques pesant de 15 à 30 kg.
ARS Pharmaceuticals (Nasdaq: SPRY) hat angekündigt, dass neffy® (Epinephrin-Nasalspray) jetzt auf Rezept in den USA zur Behandlung von Typ-I-Allergien, einschließlich Anaphylaxie, für Erwachsene und Kinder mit einem Gewicht von ≥30 kg erhältlich ist. Die FDA hat neffy 2 mg letzten Monat genehmigt und es als erste und einzige nadelfreie Behandlung für schwere allergische Reaktionen eingestuft.
Über neffyConnect und BlinkRx können berechtigte privatversicherte Patienten zwei Einmal-neffy-Geräte für einen Eigenanteil von 25 $ erhalten. Unversicherte Patienten oder solche ohne Versicherung können neffy für 199 $ für zwei Geräte erwerben. Das Unternehmen bietet auch kostenlose Tragetaschen an und hat verschiedene Unterstützungsprogramme für Patienten implementiert, um die Zugänglichkeit zu gewährleisten.
ARS Pharmaceuticals plant, den Zugang zu EURneffy® in Europa zu erweitern und hat einen sNDA für die Anwendung von neffy 1 mg bei pädiatrischen Patienten mit einem Gewicht von 15 bis 30 kg eingereicht.
- First and only FDA-approved needle-free epinephrine treatment for severe allergic reactions
- Now available by prescription across the U.S.
- Affordable pricing options: $25 co-pay for eligible insured patients, $199 for uninsured patients
- European Commission approval for EURneffy obtained
- Potential market expansion with sNDA submission for pediatric use (15-30 kg)
- None.
Visit neffy.com to “Get neffy Now” and access the comprehensive patient assistance programs available through neffyConnect
SAN DIEGO, Sept. 23, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that neffy® (epinephrine nasal spray) is now available to patients and caregivers by prescription across the U.S. The U.S. Food and Drug Administration (FDA) approved neffy 2 mg last month for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.).
Through neffyConnect, and in partnership with online pharmacy BlinkRx, eligible commercially insured patients will pay
“The introduction of neffy as the first and only needle-free treatment option for patients and caregivers living with severe allergic reactions marks a turning point for ARS Pharmaceuticals and the severe allergy community. Since approval, we have been partnering with healthcare providers, payers, and patient advocates to ensure access for patients,” said Eric Karas, chief commercial officer of ARS Pharmaceuticals. “Pharmacies are processing prescriptions, our supply chain is fully operational, and most importantly, the first patients are now receiving neffy.”
In addition to scheduling an appointment with healthcare providers to prescribe neffy, other options for patients who need to obtain a prescription include visiting neffy.com and selecting the “Get neffy Now” button. They can request neffy either through their existing healthcare provider or via a virtual consultation with a licensed physician. Both options are supported by neffyConnect, a service designed to help patients with access and financial assistance. ARS Pharmaceuticals is also offering free carrying cases that hold two single-use neffy devices with instructions for use, encouraging having neffy conveniently available when needed.
“The introduction of neffy is welcomed by the healthcare community,” said Dr. Carlos Camargo, MD DrPH, Professor of Emergency Medicine at Massachusetts General Hospital and Harvard Medical School. “neffy changes the paradigm when it comes to treatment options for patients and families living with severe allergic reactions — and the way in which healthcare providers practice. Epinephrine auto-injectors have needles and this can be intimidating for patients. This can lead to hesitancy in carrying and in using the life-saving devices, and often results in patients failing to treat before seeking emergency medical assistance. neffy provides a fast, easy-to-carry, easy-to-administer alternative that we anticipate will result in more people carrying their epinephrine device and treating their allergic event earlier. These changes are likely to lead to better clinical outcomes and less need for emergency room visits.”
“Years of dedication from the entire allergy community and healthcare providers have paved the way for neffy as the first needle-free epinephrine treatment for severe allergies,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharmaceuticals. “We are so proud of our team members who have worked diligently from conception through FDA approval to make neffy available. Now that people can begin using neffy, we are looking forward to seeing how it positively impacts up to 40 million people in the U.S. who experience severe allergic reactions.”
Expanding Access in Europe, Pediatric Indications
In addition to its U.S. launch, ARS Pharmaceuticals plans to expand access to EURneffy® (trade name for neffy in the EU) internationally in partnership with an EU-based pharmaceutical partner. On August 22, 2024, the European Commission approved EURneffy (adrenaline nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in the EU. The company expects EURneffy to be available in certain EU Member States by Q4 2024.
ARS Pharmaceuticals has also submitted a supplemental New Drug Application (sNDA) to the FDA for the use of neffy 1 mg in pediatric patients weighing 15 to 30 kg (33 to 66 lbs.), further broadening its potential to protect vulnerable populations from severe allergic reactions.
About Type I Allergic Reactions including Anaphylaxis
Type I severe 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 auto-injectors 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 severe allergic reactions due to food, venom or insect stings. Of those, only 3.3 million currently have an active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.
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 ARS Pharmaceuticals, Inc. ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from severe 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 US 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 platforms through which neffy will be accessible, including BlinkRx; neffy, neffy.com, and neffyConnect’s potential benefits to patients and caregivers; the needle-free profile of neffy potentially increasing the likelihood that patients may both carry and administer epinephrine; the potential market and demand for neffy; the timelines for commercialization of EURneffy in the European Union; ARS Pharmaceuticals’s marketing and commercialization strategies, including potential partnerships in foreign jurisdictions; 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 “can,” “could,” “expects,” “likely,” “may,” “plans,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’s 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: the ability to obtain and maintain regulatory approval for neffy; 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’s 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’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission (SEC) on August 6, 2024. This and other documents ARS Pharmaceuticals files with the SEC can also be accessed on ARS Pharmaceuticals’s website at ir.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.
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
Photos accompanying this announcement are available at
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FAQ
What is the price of neffy (SPRY) for commercially insured patients?
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