Children With Meals Allergy symptoms is sharing this press launch from ARS Prescribed drugs to carry you the newest analysis information rapidly.
[PRESS RELEASE]
ARS Prescribed drugs Publicizes FDA Approval of neffy® 1 mg (epinephrine nasal spray) for Kind I Allergic Reactions, Together with Anaphylaxis, in Pediatric Sufferers Weighing 15 to < 30 Kilograms
March 5, 2025
neffy 1 mg is the primary and solely needle-free epinephrine remedy permitted for youthful kids
SAN DIEGO, March 05, 2025 (GLOBE NEWSWIRE) — ARS Prescribed drugs, Inc. (Nasdaq: SPRY), a biopharmaceutical firm devoted to empowering at-risk sufferers and caregivers to raised defend themselves from allergic reactions that might result in anaphylaxis, introduced at the moment that the U.S. Meals and Drug Administration (FDA) has permitted neffy® 1 mg (epinephrine nasal spray) for the remedy of Kind I Allergic Reactions, together with anaphylaxis, in kids who’re aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the primary vital innovation within the supply of epinephrine for this affected person inhabitants in additional than 35 years.
Within the normal inhabitants, roughly one in 13 kids have extreme meals allergy symptoms, and greater than 40 % have skilled extreme reactions.1 Regardless of the clear hyperlink between early epinephrine use and higher outcomes, analysis exhibits that roughly 40 % of sufferers delay remedy2, and 56 % of caregivers worry utilizing needle-based auto-injectors on their baby3. neffy eliminates needles, delivering a exact epinephrine dose through a easy nasal spray, virtually immediately, with no nasal maintain time required.
“Immediately’s FDA approval of neffy 1 mg marks a serious milestone in the direction of our efforts to rework the administration of extreme allergic reactions,” says Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “Many kids and caregivers worry needle-based auto-injectors, which may delay lifesaving remedy. neffy’s needle-free, easy-to-use design addresses this unmet want, providing households a long-awaited various. With almost 4 out of 10 U.S. epinephrine prescriptions written for kids underneath the age of 18—and almost a 3rd of these for kids weighing 15 to 30 kilograms4 —we consider neffy 1 mg will enhance entry to a needle-free choice for the remedy of extreme allergy symptoms and scale back hesitation in treating this susceptible group. It is going to additionally eradicate dangers like unintended needle accidents to kids or caregivers.”
The approval of neffy 1 mg relies on information from intensive medical trials, together with pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and grownup topics that had been per these of epinephrine injection merchandise. Hostile occasions in pediatric trials had been usually delicate and transient. Human issue research additionally present kids as younger as 10 can use neffy successfully by following directions, and that even untrained people, equivalent to babysitters or lecturers, can successfully administer neffy. The gadget has a shelf-life of 24 months at room temperature and tolerance to temperature exposures as much as 122°F (50°C) based mostly on testing for as much as 3 months. If by chance frozen, neffy will be thawed with out affect on the product high quality and reliability.
“The supply of a needle-free epinephrine choice for kids is a breakthrough within the remedy of extreme allergic reactions,” says Dr. David Fleischer, Part Head of Allergy & Immunology, and Professor of Pediatrics, at Youngsters’s Hospital Colorado. “Many individuals wait to manage epinephrine till signs progress or take antihistamines as a primary line of protection as a result of they’re afraid of injection. neffy’s small, user-friendly design addresses these challenges, empowering individuals to really carry epinephrine and act rapidly and confidently throughout an allergic emergency. This innovation will seemingly considerably enhance well being outcomes and improve high quality of life.”
ARS Pharma is dedicated to entry and affordability, and neffy 1 mg is predicted to be out there within the U.S. by the tip of Might 2025. The neffyConnect program offers sufferers, caregivers, and healthcare professionals with data to information their remedy journey, particulars about remedy success companies, monetary help and navigating insurance coverage necessities. Most commercially insured sufferers pays not more than $25 for 2 single-use neffy units by a co-pay financial savings program. The co-pay financial savings card will be accessed at neffy.com and downloaded to an Apple Pockets and supplied to the pharmacy. If the product isn’t coated by insurance coverage, the money value of $199 for 2 doses is accessible by BlinkRx and coupon will be downloaded from GoodRx to be used at native retail pharmacies. For sure uninsured or underinsured U.S. residents assembly eligibility standards and exhausted all different choices, the ARS Pharma Affected person Help Program (PAP) will present neffy for free of charge.
Eligible colleges taking part within the neffyinSchools program can obtain neffy 1 mg upon availability. For extra data, and to register for neffyConnect, go to www.neffy.com.
The approval of neffy 1 mg follows FDA approval for neffy 2 mg on August 9, 2024 for kids and adults weighing 30kg ( 66 lb.), and approval for EURneffy within the EU by the European Fee on August 22, 2024.
About neffy®
neffy is a nasal spray used for emergency remedy of allergic reactions together with anaphylaxis, in adults and youngsters aged 4 years and older who weigh 33 lbs. or higher.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy is indicated for emergency remedy of sort I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers aged 4 years and older who weigh 33 lbs. or higher.
IMPORTANT SAFETY INFORMATION
neffy incorporates epinephrine, a drugs used to deal with allergic emergencies (anaphylaxis). Anaphylaxis will be life-threatening, can occur in minutes, and will be brought on by stinging and biting bugs, allergy injections, meals, medicines, train, or different unknown causes.
At all times carry two neffy nasal sprays with you as a result of you could not know when anaphylaxis could occur and since you could want a second dose of neffy if signs proceed or come again. Every neffy incorporates a single dose of epinephrine. neffy is to be used within the nostril solely.
Use neffy straight away, as quickly as you discover signs of an allergic response. If signs proceed or worsen after the primary dose of neffy, a second dose is required. If wanted, administer a second dose utilizing a brand new neffy in the identical nostril beginning 5 minutes after the primary dose. Get emergency medical assist for additional remedy of the allergic emergency (anaphylaxis), if wanted after utilizing neffy.
Inform your healthcare supplier if in case you have underlying structural or anatomical nasal situations, about all of the medicines you are taking, and about all of your medical situations, particularly if in case you have coronary heart issues, kidney issues, low potassium in your blood, Parkinson’s illness, thyroid issues, hypertension, diabetes, are pregnant or plan to grow to be pregnant, or plan to breastfeed.
Inform your healthcare supplier for those who take or use different nasal sprays or water tablets (diuretics) or for those who take medicines to deal with despair, irregular coronary heart beats, Parkinson’s illness, coronary heart illness, thyroid illness, medicines utilized in labor, and medicines to deal with allergy symptoms. neffy and different medicines could have an effect on one another, inflicting unwanted effects. neffy could have an effect on the best way different medicines work, and different medicines could have an effect on how neffy works.
neffy could trigger severe unwanted effects. You probably have sure medical situations or take sure medicines, your situation could worsen, or you will have extra or longer lasting unwanted effects if you use neffy.
Widespread unwanted effects of neffy embrace: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nostril bleed, nostril ache, sneezing, runny nostril, dry nostril or throat, tingling sensation, together with within the nostril, feeling drained, dizziness, nausea, and vomiting.
Inform your healthcare supplier if in case you have any unwanted effects that trouble you or that don’t go away after utilizing neffy.
These will not be the entire attainable unwanted effects of neffy. Name your healthcare supplier for medical recommendation about unwanted effects. To report unwanted effects, contact ARS Prescribed drugs Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the total Prescribing Info and Affected person Info for neffy.
About Kind I Allergic Reactions Together with Anaphylaxis
Kind I allergic reactions are severe and doubtlessly life-threatening occasions that may happen inside minutes of publicity to an allergen and require speedy remedy with epinephrine, the one FDA-approved remedy for these reactions. Whereas epinephrine auto-injectors have been proven to be extremely efficient, there are nicely printed limitations that end in many sufferers and caregivers delaying or not administering remedy in an emergency state of affairs. These limitations embrace worry of the needle, lack of portability, needle-related security issues, lack of reliability, and complexity of the units. There are roughly 40 million individuals in the USA who expertise Kind I Allergic reactions. Of this group, over the past three years, roughly 20 million individuals have been recognized and handled for extreme Kind I allergic reactions which will result in anaphylaxis, however (in 2023, for instance) solely 3.2 million crammed their lively epinephrine auto-injector prescription, and of these, solely half constantly carry their prescribed auto-injector. Even when sufferers or caregivers carry an auto-injector, greater than half both delay or don’t administer the gadget when wanted in an emergency.
About ARS Prescribed drugs, Inc.
ARS Prescribed drugs is a biopharmaceutical firm devoted to empowering at-risk sufferers and their caregivers to raised defend sufferers from allergic reactions that might result in anaphylaxis. The Firm is commercializing neffy® (commerce identify EURneffy® within the EU) (beforehand known as ARS-1), an epinephrine nasal spray indicated within the U.S. for emergency remedy of Kind I allergic reactions, together with anaphylaxis, grownup and pediatric sufferers 4 years of age and older who weigh 15 kg or higher, and within the EU for emergency remedy of allergic reactions (anaphylaxis) resulting from insect stings or bites, meals, medicinal merchandise, and different allergens in addition to idiopathic or train induced anaphylaxis in adults and youngsters who weigh 30 kg or higher. For extra data, go to www.ars-pharma.com.
Ahead Wanting Statements
Statements on this press launch that aren’t purely historic in nature are “forward-looking statements” inside the which means of the Non-public Securities Litigation Reform Act of 1995. These statements embrace, however will not be restricted to: the expectation that neffy will save lives; the effectiveness of neffy; neffyConnect’s potential to assist sufferers and HCPs entry monetary help and drugs success companies; ARS Prescribed drugs’ industrial protection targets and the timing thereof; the anticipated timing for product availability of neffy 1 mg; neffy’s potential to improved well being outcomes and high quality of life; neffy’s shelf life and its effectiveness after being topic to excessive temperatures; and different statements that aren’t historic reality. As a result of such statements are topic to dangers and uncertainties, precise outcomes could differ materially from these expressed or implied by such forward-looking statements. Phrases equivalent to “anticipate,” “expects,” “if,” “could,” “potential,” “on observe to,” “plans,” “will,” “would,” and related expressions are meant to establish forward-looking statements. These forward-looking statements are based mostly upon ARS Prescribed drugs’ present expectations and contain assumptions which will by no means materialize or could show to be incorrect. Precise outcomes and the timing of occasions may differ materially from these anticipated in such forward-looking statements because of varied dangers and uncertainties, which embrace, with out limitation: potential security and different issues from neffy; the flexibility to take care of regulatory approval for neffy in its at the moment permitted indications the scope, progress and enlargement of growing and commercializing neffy; the potential for governments and payors to delay, restrict or deny protection for neffy; the dimensions and progress of the market therefor and the speed and diploma of market acceptance thereof vis-à-vis intramuscular injectable merchandise; ARS Prescribed drugs’ potential to guard its mental property place; and the affect of presidency legal guidelines and rules. Further dangers and uncertainties that might trigger precise outcomes and outcomes to vary materially from these contemplated by the forward-looking statements are included underneath the caption “Danger Elements” in ARS Prescribed drugs’ Quarterly Report on Type 10-Q for the quarter ended September 30, 2024, filed with the Securities and Change Fee (“SEC”) on November 13, 2024. These paperwork can be accessed on ARS Prescribed drugs’ web site at www.ars-pharma.com by clicking on the hyperlink “Financials & Filings” underneath the “Traders & Media” tab.
The forward-looking statements included on this press launch are made solely as of the date hereof. ARS Prescribed drugs assumes no obligation and doesn’t intend to replace these forward-looking statements, besides as required by legislation. For extra data, go to www.ars-pharma.com, and observe us on LinkedIn and X.
References:
- Meals Allergy Analysis & Training. Info and Statistics. Out there at Info and Statistics – FoodAllergy.org. Accessed January 24, 2025.
- Rooney E, et al. Poster Presentation at ACAAI 2022 (Louisville, KY).
- Chad L, Ben-Shoshan M, Asai Y, et al. A majority of oldsters of kids with peanut allergy worry utilizing the epinephrine auto-injector. Allergy. 2013;68(12):1605-1609. https://doi.org/10.1111/all.12262.
- ARS Information on File, 2025
