Qualifying private and non-private Ok-12 Colleges within the U.S. will likely be eligible to obtain two free cartons (4 single use doses) of neffy® (epinephrine nasal spray) 2mg to be used in emergency therapy of allergic reactions together with anaphylaxis
colleges are inspired to overview relevant state legal guidelines and rules to make sure neffy for undesignated use meets all necessities
SAN DIEGO, Dec. 04, 2024 (GLOBE NEWSWIRE) — ARS Prescribed drugs, Inc. (Nasdaq: SPRY), a biopharmaceutical firm devoted to empowering at-risk sufferers and caregivers to higher defend themselves from allergic reactions that might result in anaphylaxis, introduced in the present day that it is going to be launching the neffyinSchools Program in January 2025. This system will present eligible private and non-private Ok-12 colleges within the U.S. the chance to obtain two cartons (4 single use doses) of neffy® (epinephrine nasal spray) 2mg to be used in emergency conditions for gratis to the college. neffy 2mg was just lately accepted for the therapy of Kind I Allergic Reactions, together with anaphylaxis, in adults and kids who weigh ≥30 kg (66 lbs.) Collaborating colleges will likely be eligible to obtain substitute doses when the product is used or expires.
Kind 1 allergic reactions could be life-threatening, can occur in minutes, and could be brought on by stinging and biting bugs, meals, remedy, train, or different unknown causes. Research present that as much as 18% of kids with meals allergic reactions have had a response from by chance consuming meals allergens whereas in school.1 As well as, 25% of extreme and doubtlessly life-threatening reactions (anaphylaxis) reported at colleges occurred in kids with no earlier analysis of meals allergy.1
“The potential for extreme allergic reactions to meals, remedy, train or insect bites can shortly end in an emergency if epinephrine will not be accessible. Since many surprising allergic reactions occur in the course of the college day, available epinephrine is essential,” says Richard Lowenthal, Co-Founder, President and CEO of ARS Prescribed drugs. “Moreover, many individuals, together with college students, have a worry of needles which may influence, delay or forestall the usage of an auto-injector. We’re dedicated to creating neffy, the one needle-free epinephrine therapy possibility, accessible freed from cost to all eligible colleges by means of our neffyinSchools program as a result of we all know neffy will save lives. We additionally perceive that there are at the moment many challenges for colleges that inventory epinephrine. neffy is safer for varsity workers when administering epinephrine in allergy emergency conditions, is less complicated to dispose as neffy doesn’t comprise any sharps, and it has an extended shelf lifetime of 30 months.”
Upfront of the neffyinSchools launch, colleges are inspired to overview relevant state laws to make sure neffy meets the necessities of native epinephrine stocking and indemnification legal guidelines for undesignated use. At present, 49 states and Washington DC have laws in place to permit colleges to inventory epinephrine. The main points of every state’s laws, and skill to inventory neffy particularly, might fluctuate. For states that don’t but permit for neffy as a result of stocking protocols haven’t been up to date to mirror this product and/or route of administration, college directors might must contact their state legislator to request modifications to state laws to make sure college personnel are indemnified from legal responsibility to be used of FDA accepted epinephrine merchandise. Many affected person advocacy teams have info and sources on this subject that may be discovered right here.
A webinar will likely be hosted on December 12 to offer info to highschool nurses and adminstrators concerning the neffyinSchools program, normal details about neffy in addition to coaching and different on-line sources. Following this system’s official launch in January 2025, ARS Pharma will present utility directions to varsities to obtain neffy 2mg.
Extra details about this program could be discovered at www.ars-pharma.com and www.neffy.com below the Neighborhood Program tab. Further updates will likely be offered on ARS LinkedIn and X pages. The neffyinSchools program is topic to the extra detailed phrases and situations which will likely be accessible on the Firm’s web site previous to the official launch of the neffyinSchools program.
About neffyinSchools
ARS is dedicated to working with our communities to offer important epinephrine in colleges. Eligible private and non-private Ok-12 colleges within the U.S. (excluding territories) will be capable to obtain two cartons (4 single use doses) of neffy 2mg for adults and kids who weigh ≥30 kg (66 lbs.), in emergency conditions. The neffyinSchools program is just for undesignated use, and kids with prescriptions for epinephrine from their healthcare supplier should proceed to produce remedy to their college in accordance with college pointers. Colleges should overview 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 1mg dose was granted precedence overview by the FDA and has a PDUFA date set for March 6, 2025. If accepted, neffy 1mg will likely be accessible to varsities for college students who weigh between 33 and 66 lbs. The neffyinSchools program is topic to the extra detailed phrases and situations which will likely be accessible on the Firm’s web site previous to the official launch of the neffyinSchools program
About neffy®
neffy is an intranasal epinephrine product for sufferers with Kind I allergic reactions together with meals, medicines, and bug bites that might result in life-threatening anaphylaxis.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy 2 mg is indicated for emergency therapy of Kind I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers who weigh 30 kg or larger.
IMPORTANT SAFETY INFORMATION
It is suggested that sufferers are prescribed and have speedy entry to 2 neffy nasal sprays always. Within the absence of scientific enchancment or if signs worsen after preliminary therapy, 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 therapy 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 improve systemic absorption of nasal merchandise, together with neffy.
Sufferers with sure medical situations or who take sure medicines for allergic reactions, despair, thyroid problems, diabetes, and hypertension, could also be at larger danger for antagonistic reactions.
Epinephrine can quickly exacerbate the underlying situation or improve 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.
Hostile reactions to neffy might embody 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 will not be the entire attainable negative effects of neffy. To report suspected antagonistic reactions, contact ARS Prescribed drugs Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For added info on neffy, please see Full Prescribing Info at www.neffy.com.
About Kind I Allergic Reactions Together with Anaphylaxis
Kind I allergic reactions are critical and doubtlessly life-threatening occasions that may happen inside minutes of publicity to an allergen and require speedy therapy with epinephrine, the one FDA-approved remedy for these reactions. Whereas epinephrine autoinjectors 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 embody worry of the needle, lack of portability, needle-related security considerations, lack of reliability, and complexity of the gadgets. There are roughly 40 million folks in the USA who expertise Kind I allergic reactions. Of this group, during the last three years, roughly 20 million folks have been identified and handled for extreme Kind I allergic reactions that will result in anaphylaxis, however (in 2023, for instance) solely 3.2 million stuffed their energetic 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 system 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 higher defend sufferers from allergic reactions that might result in anaphylaxis. The Firm is commercializing neffy® 2 mg (commerce title EURneffy® within the EU) (beforehand known as ARS-1), an epinephrine nasal spray indicated within the U.S. for emergency therapy of Kind I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers who weigh 30 kg or larger, and within the EU for emergency therapy of allergic reactions (anaphylaxis) as a result of insect stings or bites, meals, medicinal merchandise, and different allergens in addition to idiopathic or train induced anaphylaxis in adults and kids who weigh 30 kg or larger. For extra info, 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” inside the which means of the Personal Securities Litigation Reform Act of 1995. These statements embody, however will not be restricted to: the anticipated timing and launch of neffyinSchools; the needle-free profile of neffy and making neffy accessible for gratis to eligible private and non-private Ok-12 colleges growing the probability that such colleges will each carry and administer adrenaline to college students experiencing an allergic response; the expectation that neffy will save lives; the potential for stocking neffy to qualify below indemnification legal guidelines for undesignated use; 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 comparable to “anticipate,” “expects,” “if,” “might,” “potential,” “on monitor to,” “plans,” “will,” “would,” and comparable expressions are meant to establish forward-looking statements. These forward-looking statements are based mostly upon ARS Prescribed drugs’ present expectations and contain assumptions that 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 because of numerous dangers and uncertainties, which embody, with out limitation: potential security and different problems from neffy; ARS Prescribed drugs might not obtain the anticipated advantages from the neffyinSchools program; private and non-private colleges could also be take part within the neffyinSchools program to the diploma or on the timelines anticipated by ARS Prescribed drugs the scope, progress and growth of creating and commercializing neffy; the potential for 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’ capability to guard its mental property place; the influence of presidency legal guidelines and rules; and the PDUFA goal motion date could also be delayed as a result of numerous components exterior ARS Prescribed drugs’ management. Further dangers and uncertainties that might trigger precise outcomes and outcomes to vary materially from these contemplated by the forward-looking statements are included below the caption “Threat 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 may also be accessed on ARS Prescribed drugs’ web site at www.ars-pharma.com by clicking on the hyperlink “Financials & Filings” below 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 regulation.
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
1Facilities for Illness Management and Prevention. Voluntary Pointers for Managing Meals Allergic reactions in Colleges and Early Care and Schooling Packages. Washington, DC: US Division of Well being and Human Companies; 2013.
Observe of disclosure: ARS Pharma is an advertiser with SnackSafely.com.
