For these of you anxiously ready for a needle-free epinephrine various in your younger little one, we’re thrilled to announce that the FDA has accredited a pediatric model of neffy — the emergency epinephrine nasal spray from ARS Pharma — for youths weighing 33 to lower than 66 kilos.
Right here follows the ARS press launch saying the information.
ARS Prescribed drugs Publicizes FDA Approval of neffy® 1 mg (epinephrine nasal spray) for Sort I Allergic Reactions, Together with Anaphylaxis, in Pediatric Sufferers Weighing 15 to < 30 Kilograms
neffy 1 mg is the primary and solely needle-free epinephrine therapy accredited for youthful youngsters
SAN DIEGO, March 5, 2025 – 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 right now that the U.S. Meals and Drug Administration (FDA) has accredited neffy® 1 mg (epinephrine nasal spray) for the therapy of Sort I Allergic Reactions, together with anaphylaxis, in youngsters who’re aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the primary important innovation within the supply of epinephrine for this affected person inhabitants in additional than 35 years.
Within the common inhabitants, roughly one in 13 youngsters have extreme meals allergic reactions, and greater than 40 % have skilled extreme reactions.1 Regardless of the clear hyperlink between early epinephrine use and higher outcomes, analysis reveals that roughly 40 % of sufferers delay therapy2, and 56 % of caregivers concern utilizing needle-based auto-injectors on their little one3. neffy eliminates needles, delivering a exact epinephrine dose through a easy nasal spray, nearly immediately, with no nasal maintain time required.
“Immediately’s FDA approval of neffy 1 mg marks a serious milestone in direction of our efforts to rework the administration of extreme allergic reactions,” says Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “Many youngsters and caregivers concern needle-based auto-injectors, which may delay lifesaving therapy. 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 beneath the age of 18—and almost a 3rd of these for kids weighing 15 to 30 kilograms4 —we imagine neffy 1 mg will enhance entry to a needle-free choice for the therapy of extreme allergic reactions and cut back hesitation in treating this susceptible group. It is going to additionally get rid of dangers like unintentional needle accidents to youngsters or caregivers.”
The approval of neffy 1 mg is predicated on knowledge from in depth scientific trials, together with pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and grownup topics that had been in step with these of epinephrine injection merchandise. Hostile occasions in pediatric trials had been usually delicate and transient. Human issue research additionally present youngsters as younger as 10 can use neffy successfully by following directions, and that even untrained people, similar 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) primarily based on testing for as much as 3 months. If by accident frozen, neffy could be thawed with out influence on the product high quality and reliability.
“The supply of a needle-free epinephrine choice for kids is a breakthrough within the therapy of extreme allergic reactions,” says Dr. David Fleischer, Part Head of Allergy & Immunology, and Professor of Pediatrics, at Kids’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 folks to really carry epinephrine and act shortly and confidently throughout an allergic emergency. This innovation will doubtless considerably enhance well being outcomes and improve high quality of life.”
ARS Pharma is dedicated to entry and affordability, and neffy 1 mg is anticipated to be out there within the U.S. by the tip of Might 2025. The neffyConnectprogram gives sufferers, caregivers, and healthcare professionals with data to information their therapy journey, particulars about medicine achievement companies, monetary assist and navigating insurance coverage necessities. Most commercially insured sufferers can pay not more than $25 for 2 single-use neffy units by way of a co-pay financial savings program. The co-pay financial savings card could be accessed at neffy.com and downloaded to an Apple Pockets and supplied to the pharmacy. If the product isn’t lined by insurance coverage, the money value of $199 for 2 doses is on the market by way of BlinkRx and coupon could 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 faculties collaborating within the neffyinSchoolsprogram can obtain neffy 1 mg upon availability. For extra data, and to register for neffyJoin, 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 therapy of allergic reactions together with anaphylaxis, in adults and youngsters aged 4 years and older who weigh 33 lbs. or better.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy is indicated for emergency therapy of kind I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers aged 4 years and older who weigh 33 lbs. or better.
IMPORTANT SAFETY INFORMATION
neffy accommodates epinephrine, a drugs used to deal with allergic emergencies (anaphylaxis). Anaphylaxis could be life-threatening, can occur in minutes, and could be attributable to stinging and biting bugs, allergy injections, meals, medicines, train, or different unknown causes.
All the time carry two neffy nasal sprays with you as a result of you could not know when anaphylaxis might occur and since you could want a second dose of neffy if signs proceed or come again. Every neffy accommodates a single dose of epinephrine. neffy is to be used within the nostril solely.
Use neffy immediately, 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 therapy of the allergic emergency (anaphylaxis), if wanted after utilizing neffy.
Inform your healthcare supplier if in case you have underlying structural or anatomical nasal circumstances, about all of the medicines you’re taking, and about all of your medical circumstances, 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 change into pregnant, or plan to breastfeed.
Inform your healthcare supplier in the event you take or use different nasal sprays or water tablets (diuretics) or in the event you take medicines to deal with melancholy, irregular coronary heart beats, Parkinson’s illness, coronary heart illness, thyroid illness, medicines utilized in labor, and medicines to deal with allergic reactions. neffy and different medicines might have an effect on one another, inflicting unintended effects. neffy might have an effect on the way in which different medicines work, and different medicines might have an effect on how neffy works.
neffy might trigger critical unintended effects. When you’ve got sure medical circumstances or take sure medicines, your situation might worsen, or you will have extra or longer lasting unintended effects while you use neffy.
Frequent unintended 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 unintended effects that trouble you or that don’t go away after utilizing neffy.
These will not be all the potential unintended effects of neffy. Name your healthcare supplier for medical recommendation about unintended effects. To report unintended 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 complete Prescribing Data and Affected person Data for neffy.
About Sort I Allergic Reactions Together with Anaphylaxis
Sort I allergic reactions are critical and probably life-threatening occasions that may happen inside minutes of publicity to an allergen and require rapid therapy with epinephrine, the one FDA-approved medicine for these reactions. Whereas epinephrine auto-injectors have been proven to be extremely efficient, there are effectively revealed limitations that end in many sufferers and caregivers delaying or not administering therapy in an emergency state of affairs. These limitations embrace concern of the needle, lack of portability, needle-related security issues, lack of reliability, and complexity of the units. There are roughly 40 million folks in the US who expertise Sort I Allergic reactions. Of this group, over the past three years, roughly 20 million folks have been recognized and handled for extreme Sort I allergic reactions which will result in anaphylaxis, however (in 2023, for instance) solely 3.2 million crammed their energetic epinephrine auto-injector prescription, and of these, solely half persistently 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 therapy of Sort I allergic reactions, together with anaphylaxis, grownup and pediatric sufferers 4 years of age and older who weigh 15 kg or better, and within the EU for emergency therapy of allergic reactions (anaphylaxis) because of 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 better. For extra data, go to www.ars-pharma.com.
Ahead Trying Statements
Statements on this press launch that aren’t purely historic in nature are “forward-looking statements” throughout the that 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 ofneffy; neffyJoin’s potential to assist sufferers and HCPs entry monetary assist and drugs achievement companies; ARS Prescribed drugs’ industrial protection objectives 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 might differ materially from these expressed or implied by such forward-looking statements. Phrases similar to “anticipate,” “expects,” “if,” “might,” “potential,” “on monitor to,” “plans,” “will,” “would,” and comparable expressions are meant to determine forward-looking statements. These forward-looking statements are primarily based upon ARS Prescribed drugs’ present expectations and contain assumptions which will by no means materialize or might show to be incorrect. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements on account of numerous dangers and uncertainties, which embrace, with out limitation: potential security and different issues from neffy; the power to take care of regulatory approval for neffy in its at present accredited indications the scope, progress and enlargement of creating and commercializing neffy; the potential for governments and payors to delay, restrict or deny protection for neffy; the scale and development 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 influence of presidency legal guidelines and laws. Further dangers and uncertainties that might trigger precise outcomes and outcomes to vary materially from these contemplated by the forward-looking statements are included beneath 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 Trade Fee (“SEC”) on November 13, 2024. These paperwork may also be accessed on ARS Prescribed drugs’ web site at www.ars-pharma.com by clicking on the hyperlink “Financials & Filings” beneath the “Buyers & 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 comply with us on LinkedIn and X.
ARS Investor Contact:
Justin Chakma
ARS Prescribed drugs
justinc@ars-pharma.com
ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com
References:
- Meals Allergy Analysis & Training. Details and Statistics. Accessible at Details and Statistics – FoodAllergy.org. Accessed January 24, 2025.
- Rooney E, et al. Poster Presentation at ACAAI 2022 (Louisville, KY).
- 3. Chad L, Ben-Shoshan M, Asai Y, et al. A majority of fogeys of kids with peanut allergy concern utilizing the epinephrine auto-injector. Allergy. 2013;68(12):1605-1609.
- ARS Knowledge on File, 2025
Notice of Disclosure: ARS Pharma is an advertiser with SnackSafely.com.
