ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy® 1 mg (epinephrine nasal spray) Label
Rhea-AI Summary
ARS Pharmaceuticals (Nasdaq: SPRY) announced FDA approval to remove the age requirement for neffy 1 mg, allowing use in all children and adults who weigh ≥33 lbs. (15 kg) for emergency treatment of Type 1 allergic reactions, including anaphylaxis.
The label also adds storage guidance (blister or neffy carrying case); ARS will include a carrying case in each prescription carton beginning this summer.
Positive
- FDA approved removal of age restriction for neffy 1 mg
- Expanded patient access: children ≥33 lbs including those under age four
- Company will include a carrying case with each prescription starting this summer
Negative
- neffy 1 mg remains limited to patients weighing ≥33 lbs and <66 lbs
- Patients under 33 lbs still lack an age-agnostic needle-free epinephrine option
Key Figures
Market Reality Check
Peers on Argus
Momentum scanner shows mixed peer moves: ATAI up 2.54% and UPB down 6.44%. With SPRY up 8.35% on FDA label changes, the move appears company-specific rather than a broad biotech rotation.
Previous Fda approval Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 05 | FDA pediatric approval | Positive | -0.7% | FDA approval of neffy 1 mg for children 15–30 kg with anaphylaxis risk. |
| Sep 09 | sNDA submission | Positive | -1.7% | Submission of sNDA to expand neffy 1 mg use in 15–30 kg children. |
| Aug 09 | Initial FDA approval | Positive | +10.0% | Initial FDA approval of neffy as first needle-free epinephrine nasal spray. |
Prior FDA approval headlines for neffy produced mixed reactions: two modest declines and one strong gain, with an average move of 2.52%. The current 8.35% rise sits at the upper end of past responses to similar catalysts.
Recent FDA-related milestones for ARS Pharmaceuticals center on expanding neffy access. On Aug 09, 2024, SPRY gained U.S. FDA approval for neffy as the first needle-free epinephrine nasal spray for patients ≥30 kg. On Mar 05, 2025, FDA approved neffy 1 mg for younger pediatric patients 15–30 kg. A Sep 09, 2024 sNDA targeted further pediatric use. Today’s removal of age criteria for the 1 mg dose continues this progression in broadening the eligible patient population.
Historical Comparison
In the past, three FDA-approval-tagged neffy milestones averaged a 2.52% move. Today’s 8.35% reaction to broader label access stands noticeably above that pattern.
Historical FDA events show stepwise expansion: initial neffy approval, then pediatric 1 mg approval, followed by broader pediatric filings. The current label change removing age limits for the 1 mg dose represents another incremental broadening of the treated population within the established weight bands.
Market Pulse Summary
This announcement expands neffy’s 1 mg label by removing age limits for patients weighing ≥33 lbs., adding flexibility for caregivers of younger children while maintaining existing weight-based dosing. The FDA also clarified storage and use under real-world conditions, including temperature excursions up to 122°F and guidance around sniffing and freezing. In context of prior neffy approvals and submissions, this step continues a multi-year effort to broaden eligible patient groups. Investors may watch future uptake data across the 33–66 lb pediatric segment and additional regulatory updates.
Key Terms
anaphylaxis medical
epinephrine medical
nasal spray medical
pediatric medical
blister packaging technical
AI-generated analysis. Not financial advice.
Children were previously required to weigh ≥33 lbs. and <66 lbs. and be at least four years of age to receive neffy 1 mg dose - approval enables families of younger children within the weight range to access a needle-free epinephrine without age restrictions
Updated labeling recommends storage in blister packaging or a neffy carrying case; ARS Pharma currently makes carrying cases available and will include one with each prescription beginning this summer
SAN DIEGO, March 27, 2026 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, announced today that the U.S. Food and Drug Administration (FDA) has approved updating the neffy® 1 mg (epinephrine nasal spray) prescribing information to remove the age criteria so all children and adults who weigh 33 lbs. or more can utilize neffy for the emergency treatment of Type 1 allergic reactions, including anaphylaxis. Prior to the update, pediatric patients needed to meet a weight requirement and be at least four years of age. Additionally, the label update recommends patients carry neffy in the blister packaging or in the neffy carrying case. The company currently offers patients a case designed specifically to hold two neffy devices, free of charge, at www.neffy.com and will begin including the carrying case in each prescription carton this summer.
“We are very pleased that based on clinical data presented to FDA for neffy, that the Agency removed the age requirement in the indication. This is a major advancement for the families with small children who live with the constant worry of severe allergic reactions in their youngest children,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “Approximately one-quarter of patients requiring epinephrine are children weighing ≥33 lbs. and <66 lbs., including approximately
"Severe allergic reactions are a major concern in early childhood and parents often delay treatment because they are afraid of hurting their child with a needle-injector or accidentally injecting themselves,” said Dr. Nicole Chase, MD, Allergy/Immunology and Pediatrics. “Having a needle-free epinephrine treatment available for anyone who meets the weight criteria is an important step forward, in broadening access, lowering treatment hurdles, and supporting caregivers who are doing everything they can to protect their children.”
Other label updates from the FDA included more flexible guidance around sniffing, temperature excursions and freezing. Specifically, language was updated to explain that even if a patient sniffs in after dosing with neffy that management of the event is the same as without sniffing, and if symptoms improve within 5 minutes, additional dosing of neffy is not necessary. neffy may be used once thawed if accidentally frozen, and high temperature excursions (up to 122oF) are allowed.
neffy is available in two doses. neffy 1 mg is for patients who weigh ≥33 lbs. and <66 lbs. (15 kg to <30 kg) and neffy 2 mg is the recommended dosage for children and adults who weigh 66 lbs. (≥30 kg) or more.
About neffy®
neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children who weigh 33 lbs. or greater.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 33 lbs. or greater.
IMPORTANT SAFETY INFORMATION
neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.
Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only.
Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy.
Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed.
Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works.
neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use neffy.
Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting.
Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy.
These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals 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 full Prescribing Information and Patient Information for neffy.
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 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 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 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 ARS Pharmaceuticals, Inc.
ARS Pharma 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® (trade name EURneffy® in the EU and 优敏速® in China), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients who weigh 33 lbs. 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 patient benefits and effectiveness of neffy, including its needle-free, compact, portable and easy to use design, temperature stability and temperature-handling flexibility, and extended shelf life; evaluations, expectations and judgments regarding the impact of the updated neffy 1 mg prescribing information on families and caregivers; ARS Pharma’s plan to including a neffy carrying case with each prescription carton this summer; 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,” “believe,” “can,” “could,” “expect,” “if,” “may,” “on track to/for,” “potential,” “plan,” “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 ability to obtain and maintain regulatory approval for neffy in its currently approved indications; the scope, progress and expansion of developing and commercializing neffy; the scope, progress and expansion of developing our intranasal epinephrine technology; clinical trial results; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market for neffy and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws, regulations and policies. 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 Pharma’s Annual Report on Form 10-K for the year ended December 30, 2025, filed with the SEC on March 9, 2026. This document can also be accessed on ARS Pharma’s 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 Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit www.ars-pharma.com, and follow us on LinkedIn and X.
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
Reference:
- IQVIA MIDAS Database
FAQ
What did ARS Pharmaceuticals (SPRY) announce on March 27, 2026 about neffy 1 mg?
Who is eligible to use neffy 1 mg after the FDA label update (SPRY)?
When will ARS (SPRY) start including the neffy carrying case with prescriptions?
How did the FDA label update change storage and temperature guidance for neffy (SPRY)?
What does the label change mean for parents of children under four regarding neffy (SPRY)?
