February 20, 2025
Roughly 5 months after launch, the inclusion of neffy on these three extra formularies has expanded entry to half of all sufferers and caregivers managing Sort 1 allergic reactions, bringing the entire variety of formulary platforms overlaying neffy to 30
SAN DIEGO, Feb. 20, 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 right this moment that Cigna Healthcare, Navitus Well being Techniques and OptumRx, via their Group Buying Group (GPO) Emisar, have added neffy® (epinephrine nasal spray) to their Nationwide Formularies.
“Thousands and thousands of sufferers nationwide now have improved entry to neffy via their industrial insurance coverage, because of protection from main pharmaceutical profit managers and well being plans. neffy can even be obtainable on the lowest branded copay for sufferers insured by OptumRx, Cigna Healthcare, and Navitus Well being Techniques – with out the necessity for prior authorizations or restrictive step therapies,” stated Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “In consequence, extra sufferers will qualify for the low copay worth of $25 for neffy, once they apply the ARS Pharma copay help, and healthcare suppliers can prescribe it with out the necessity for added paperwork.”
“This announcement additionally underscores the essential demand for a nasal spray epinephrine choice inside the extreme allergy group and we stay dedicated to making sure continued entry for as many sufferers and caregivers as doable. Whereas Emisar represents each OptumRx and UnitedHealthcare as their GPO presently solely OptumRx has agreed to the Emisar phrases. ARS Pharma is working carefully with UnitedHealthcare, as one of many nation’s largest healthcare suppliers, so as to add neffy to their formulary as quickly as doable,” stated Lowenthal.
The addition of neffy to those formularies improves protection for the roughly 20 million individuals who have been recognized and handled for the extra extreme Sort I allergic reactions that will result in anaphylaxis and wish epinephrine remedy to guard themselves of their every day lives. To help sufferers in navigating protection and affordability challenges, ARS Pharma affords plenty of applications for sufferers and caregivers. For extra info, go to www.neffy.com/financial savings.
neffy 2 mg is for the therapy of Sort I Allergic Reactions, together with anaphylaxis, in adults and youngsters who weigh ≥30 kg (66 lbs.). It’s the first and solely FDA-approved epinephrine nasal spray that gives a needle-free different to conventional injectable epinephrine. It’s easy and intuitive design allows speedy administration, serving to sufferers and caregivers act rapidly and confidently, and the small dimension is straightforward to hold. Moreover, neffy has a shelf-life of 30 months and temperature exclusions as much as 122 levels Fahrenheit.
The supplemental NDA for neffy 1 mg, for youngsters over 4 years of age who weigh 15 to 30 kg, has a Prescription Drug Person Charge Act (PDUFA) goal motion date of March 6, 2025. Based mostly on evaluate timelines and topic to approval, product availability of neffy 1 mg is predicted by the top of Could 2025. ARS Pharma anticipates that by the epinephrine prescription renewal interval, which happens over the summer time for a lot of kids in the US, that faculty age kids who meet the burden and age standards can have entry to neffy.
About neffy®
neffy is an intranasal epinephrine product for sufferers with Sort I allergic reactions together with meals, medicines, 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 therapy of Sort I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers who weigh 30 kg or larger.
IMPORTANT SAFETY INFORMATION
It is strongly recommended that sufferers are prescribed and have instant 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 circumstances.
Administer with warning to sufferers who’ve coronary heart illness; epinephrine could irritate angina pectoris or produce ventricular arrhythmias. Arrhythmias, together with deadly ventricular fibrillation, have been reported, notably in sufferers with underlying cardiac illness or taking cardiac glycosides, diuretics, or anti-arrhythmics.
The presence of a sulfite in neffy shouldn’t deter use.
neffy could 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 circumstances or who take sure medicines for allergic reactions, despair, thyroid problems, diabetes, and hypertension, could also be at larger danger for hostile reactions.
Epinephrine can briefly exacerbate the underlying situation or improve signs in sufferers with the next: hyperthyroidism, Parkinson’s illness, diabetes, renal impairment. Epinephrine needs to be administered with warning in sufferers with these circumstances, together with aged sufferers and pregnant ladies.
Adversarial reactions to neffy could embody throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, stomach ache, gingival ache, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.
These are usually not the entire doable negative effects of neffy. To report suspected hostile 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 added info on neffy, please see Full Prescribing Data at www.neffy.com.
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 instant therapy with epinephrine, the one FDA-approved treatment for these reactions. Whereas epinephrine auto-injectors have been proven to be extremely efficient, there are nicely 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 units. There are roughly 40 million individuals in the US who expertise Sort I allergic reactions. Of this group, during the last three years, roughly 20 million individuals have been recognized and handled for extreme Sort I allergic reactions that 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 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 title 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, 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 youngsters who weigh 30 kg or larger. For extra info, 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 embody, however are usually not restricted to: the anticipated affect from the inclusion of neffy on OptumRx, Cigna Healthcare and Navitus Well being Techniques’ Nationwide Formularies; ARS Prescription drugs’ expectation that different payors, reminiscent of UnitedHealthcare, will comply with phrases to supply entry to neffy and the timing by which they may present such entry, the essential demand for a nasal spray epinephrine choice, the expectation that neffy will save lives; the effectiveness of neffy; the anticipated timing for product availability of neffy 1 mg; 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 reminiscent of “anticipate,” “expects,” “if,” “could,” “potential,” “on monitor to,” “plans,” “will,” “would,” and comparable expressions are supposed to determine forward-looking statements. These forward-looking statements are primarily based upon ARS Prescription drugs’ present expectations and contain assumptions that will by no means materialize or could show to be incorrect. Precise outcomes and the timing of occasions might 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 issues from neffy; ARS Prescription drugs’ reliance on its licensing companions; the flexibility to take care of regulatory approval for neffy in its at the moment accredited indication and to acquire and preserve regulatory approval for neffy for added indications; the labelling for neffy in any future indication or affected person inhabitants, if accredited; 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 scale and development of the market therefor and the speed and diploma of market acceptance thereof vis-à-vis intramuscular injectable merchandise; ARS Prescription drugs’ skill to guard its mental property place; and the affect 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 “Threat Components” in ARS Prescription 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 will also be accessed on ARS Prescription 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 Prescription drugs assumes no obligation and doesn’t intend to replace these forward-looking statements, besides as required by legislation. For extra info, go to www.ars-pharma.com, and observe us on LinkedIn and X.
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
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