College directors and nurses are inspired to evaluation relevant state legal guidelines and rules to make sure neffy® (epinephrine nasal spray) 2 mg for undesignated use meets relevant state legislation necessities
faculties can go to neffy.com/community-programs to use
SAN DIEGO, Jan. 21, 2025 (GLOBE NEWSWIRE) — ARS Prescription drugs, Inc. (Nasdaq: SPRY), a biopharmaceutical firm devoted to empowering at-risk sufferers and caregivers to higher shield themselves from allergic reactions that would result in anaphylaxis, introduced as we speak the launch of the neffyinSchools program. neffyinSchools gives eligible private and non-private Ok-12 faculties within the U.S. with the chance to obtain two cartons (4 single use doses) of neffy® (epinephrine nasal spray) 2 mg to be used in emergency conditions for gratis to the varsity by way of the College Well being Corp. SHConnect platform. neffy 2 mg is permitted for the remedy of Sort I Allergic Reactions, together with anaphylaxis, in adults and youngsters who weigh ≥30 kg (66 lbs.). Collaborating faculties will likely be eligible to obtain alternative doses when the product is used or expires.
“College nurses play a pivotal function within the well being and wellbeing of scholars. Surprising allergic reactions can occur at any time – together with through the faculty day – so it’s essential to have epinephrine available to manage by nurses and different skilled faculty officers. The neffyinSchools program will assist faculties to acquire epinephrine freed from value. This positions faculties to be prepared to supply emergency remedy for extreme allergic reactions,” stated Kenneth Mendez, President and CEO of the Bronchial asthma and Allergy Basis of America.
Life-threatening, Sort 1 allergic reactions can occur rapidly and be attributable to meals, bugs, medicine, train, or different unknown causes. It’s estimated that one-quarter of anaphylactic reactions in faculties are amongst college students with beforehand undiagnosed allergic reactions.1 Research additionally present that meals allergy impacts roughly 1 in 20 school-aged kids.2
“We’re deeply dedicated to making sure neffy is freely obtainable to all eligible Ok-12 faculties, offering life-saving epinephrine for emergency conditions with out worry or hesitation,” stated Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “neffy is a groundbreaking machine with a easy, needle-free design that we imagine will make faculties safer and higher ready to deal with anaphylaxis. Whereas anaphylaxis can progress quickly and happen at any time, many states should replace their laws to incorporate nasal supply in native epinephrine stocking and indemnification legal guidelines, for undesignated use, earlier than it may be offered to varsities.”
ARS Pharma will host a webinar for varsity nurses and directors about neffy and the neffyinSchools program on January 22, 2025. Members are inspired to register right here.
For extra data, together with particulars about affected person advocacy teams and assets for faculties, go to www.neffy.com/community-programs. For particular inquiries, please e mail CommunityPrograms@ars-pharma.com. Ongoing updates will likely be offered on ARS LinkedIn and X pages.
About neffyinSchools
ARS Pharma is dedicated to working with our communities to supply important epinephrine in faculties. Eligible private and non-private Ok-12 faculties within the U.S. (excluding territories) will be capable of obtain two cartons (4 single use doses) of neffy 2 mg for adults and youngsters who weigh ≥30 kg (66 lbs.), in emergency conditions. The neffyinSchools program is just for undesignated use, and youngsters with prescriptions for epinephrine from their healthcare supplier should proceed to produce medicine to their faculty in accordance with faculty pointers. Faculties should evaluation relevant state laws to make sure neffy meets the necessities of native epinephrine stocking and administration legal guidelines for undesignated use. The supplemental NDA for neffy 1 mg dose was granted precedence evaluation by the FDA and has a PDUFA date set for March 6, 2025. If permitted, neffy 1 mg will likely be obtainable to varsities for college students who weigh between 33 and 66 lbs.
About neffy®
neffy is an intranasal epinephrine product for sufferers with Sort I allergic reactions together with meals, drugs, and bug bites that would result in life-threatening anaphylaxis.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy 2 mg is indicated for emergency remedy of Sort I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers who weigh 30 kg or higher.
IMPORTANT SAFETY INFORMATION
It is strongly recommended that sufferers are prescribed and have rapid entry to 2 neffy nasal sprays always. Within the absence of medical enchancment or if signs worsen after preliminary remedy, administer a second dose of neffy in the identical nostril with a brand new nasal spray beginning 5 minutes after the primary dose.
neffy is to be used within the nostril solely.
Advise sufferers when to hunt emergency medical help for shut monitoring of the anaphylactic episode and within the occasion additional remedy is required.
Absorption of neffy could also be affected by underlying structural or anatomical nasal situations.
Administer with warning to sufferers who’ve coronary heart illness; epinephrine might worsen angina pectoris or produce ventricular arrhythmias. Arrhythmias, together with deadly ventricular fibrillation, have been reported, significantly in sufferers with underlying cardiac illness or taking cardiac glycosides, diuretics, or anti-arrhythmics.
The presence of a sulfite in neffy mustn’t deter use.
neffy might alter nasal mucosa for as much as 2 weeks after administration and enhance systemic absorption of nasal merchandise, together with neffy.
Sufferers with sure medical situations or who take sure drugs for allergic reactions, melancholy, thyroid problems, diabetes, and hypertension, could also be at higher threat for antagonistic reactions.
Epinephrine can quickly exacerbate the underlying situation or enhance signs in sufferers with the next: hyperthyroidism, Parkinson’s illness, diabetes, renal impairment. Epinephrine must be administered with warning in sufferers with these situations, together with aged sufferers and pregnant ladies.
Antagonistic reactions to neffy might embrace throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, belly ache, gingival ache, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.
These should not the entire attainable unwanted side effects of neffy. To report suspected antagonistic reactions, contact ARS Prescription drugs Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For extra data on neffy, please see Full Prescribing Info at www.neffy.com.
About Sort I Allergic Reactions Together with Anaphylaxis
Sort I allergic reactions are severe and probably life-threatening occasions that may happen inside minutes of publicity to an allergen and require rapid remedy with epinephrine, the one FDA-approved medicine for these reactions. Whereas epinephrine autoinjectors have been proven to be extremely efficient, there are nicely revealed limitations that end in many sufferers and caregivers delaying or not administering remedy in an emergency scenario. These limitations embrace worry of the needle, lack of portability, needle-related security issues, lack of reliability, and complexity of the gadgets. 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 identified and handled for extreme Sort I allergic reactions which will result in anaphylaxis, however (in 2023, for instance) solely 3.2 million crammed their lively epinephrine autoinjector prescription, and of these, solely half persistently carry their prescribed autoinjector. Even when sufferers or caregivers carry an autoinjector, greater than half both delay or don’t administer the machine when wanted in an emergency.
About ARS Prescription drugs, Inc.
ARS Prescription drugs is a biopharmaceutical firm devoted to empowering at-risk sufferers and their caregivers to higher shield sufferers from allergic reactions that would result in anaphylaxis. The Firm is commercializing neffy® 2 mg (commerce identify EURneffy® within the EU) (beforehand known as ARS-1), an epinephrine nasal spray indicated within the U.S. for emergency remedy of Sort I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers who weigh 30 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-Trying Statements
Statements on this press launch that aren’t purely historic in nature are “forward-looking statements” throughout the which means of the Personal Securities Litigation Reform Act of 1995. These statements embrace, however should not restricted to: the anticipated timing and launch of neffyinSchools; the needle-free profile of neffy and making neffy obtainable for gratis to eligible private and non-private Ok-12 faculties growing the chance that such faculties will each carry and administer epinephrine to college students experiencing an allergic response; the expectation that neffy will save lives; the potential for neffy to qualify underneath native and state stocking and indemnification legal guidelines for undesignated use; the anticipated timing for acquiring regulatory approval for neffy 1 mg and the provision thereof; and different statements that aren’t historic truth. 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 resembling “anticipate,” “expects,” “if,” “might,” “potential,” “on monitor to,” “plans,” “will,” “would,” and related expressions are meant to establish forward-looking statements. These forward-looking statements are based mostly upon ARS Prescription 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 may 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; ARS Prescription drugs might not obtain the anticipated advantages from the neffyinSchools program; private and non-private faculties might not take part within the neffyinSchools program to the diploma or on the timelines anticipated by ARS Prescription drugs; the scope, progress and enlargement of growing and commercializing neffy; the potential for 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; and ARS Prescription drugs’ capability to guard its mental property place; the influence of presidency legal guidelines and rules. Extra dangers and uncertainties that would trigger precise outcomes and outcomes to vary materially from these contemplated by the forward-looking statements are included underneath the caption “Danger Components” in ARS Prescription drugs’ Quarterly Report on Type 10-Q for the quarter ended September 30, 2024, filed with the Securities and Alternate Fee (“SEC”) on November 13, 2024. These paperwork may also be accessed on ARS Prescription drugs’ web site at www.ars-pharma.com by clicking on the hyperlink “Financials & Filings” underneath the “Buyers & Media” tab.
The forward-looking statements included on this press launch are made solely as of the date hereof. ARS Prescription drugs assumes no obligation and doesn’t intend to replace these forward-looking statements, besides as required by legislation.
ARS Investor Contact:
Justin Chakma
ARS Prescription drugs
justinc@ars-pharma.com
ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com
References:
- Hogue SL, Muniz R, Herrem C, Silvia S, White MV. Boundaries to the Administration of Epinephrine in Faculties. J Sch Well being. 2018 Might;88(5):396-404. doi: 10.1111/josh.12620. PMID: 29609214.
- Kao, L. M., Wang, J., Kagan, O., Russell, A., Mustafa, S. S., Houdek, D., Smith, B., & Gupta, R. (2018). College nurse views on faculty insurance policies for meals allergy and anaphylaxis. Annals of Allergy, Bronchial asthma and Immunology, 120(3), 304-309.
©2024 ARS Prescription drugs Operations, Inc. All rights reserved. “ARS Pharma,” the ARS Pharma brand design, “neffy,” the neffy brand, and the neffyconnect brand are logos or registered logos of ARS Prescription drugs Operations, Inc. Generic references to ARS Pharma confer with ARS Prescription drugs, Inc. (Nasdaq: SPRY) and/or its wholly-owned operations subsidiary.
Word of Disclosure: ARS Pharma is an advertiser with SnackSafely.com.
