Home Food Allergies neffy® Epinephrine Nasal Spray Now Obtainable Nationwide

neffy® Epinephrine Nasal Spray Now Obtainable Nationwide

September 23, 2024

Go to neffy.com to “Get neffy Now” and entry the excellent affected person help applications obtainable by neffyConnect

SAN DIEGO, Sept. 23, 2024 (GLOBE NEWSWIRE) — ARS Prescription drugs, Inc. (Nasdaq: SPRY), a biopharmaceutical firm devoted to empowering at-risk sufferers and their caregivers to higher shield sufferers from extreme allergic reactions that would result in anaphylaxis, introduced right this moment that neffy^® (epinephrine nasal spray) is now obtainable to sufferers and caregivers by prescription throughout the U.S. The U.S. Meals and Drug Administration (FDA) permitted neffy 2 mg final month for the remedy of Kind I Allergic Reactions, together with anaphylaxis, in adults and youngsters who weigh ≥30 kg (66 lbs.).

By means of neffyConnect, and in partnership with on-line pharmacy BlinkRx, eligible commercially insured sufferers pays $25 for 2 single-use neffy units by a co-pay financial savings program. For sufferers with out insurance coverage protection, or for these whose insurance coverage don’t but cowl neffy, ARS Prescription drugs is providing a money value of $199 for 2 single-use neffy units. neffy will probably be obtainable freed from cost for sufferers that qualify for the ARS Affected person Help Program. Beginning right this moment, nationwide retail pharmacies can even start stocking neffy and a $25 co-pay financial savings card could be downloaded at neffy.com to be used at pharmacies by eligible sufferers.

“The introduction of neffy as the primary and solely needle-free remedy choice for sufferers and caregivers dwelling with extreme allergic reactions marks a turning level for ARS Prescription drugs and the extreme allergy neighborhood. Since approval, we now have been partnering with healthcare suppliers, payers, and affected person advocates to make sure entry for sufferers,” stated Eric Karas, chief industrial officer of ARS Prescription drugs. “Pharmacies are processing prescriptions, our provide chain is absolutely operational, and most significantly, the primary sufferers at the moment are receiving neffy.”

Along with scheduling an appointment with healthcare suppliers to prescribe neffy, different choices for sufferers who have to acquire a prescription embody visiting neffy.com and choosing the “Get neffy Now” button. They’ll request neffy both by their present healthcare supplier or through a digital session with a licensed doctor. Each choices are supported by neffyConnect, a service designed to assist sufferers with entry and monetary help. ARS Prescription drugs can also be providing free carrying instances that maintain two single-use neffy units with directions to be used, encouraging having neffy conveniently obtainable when wanted.

“The introduction of neffy is welcomed by the healthcare neighborhood,” stated Dr. Carlos Camargo, MD DrPH, Professor of Emergency Drugs at Massachusetts Normal Hospital and Harvard Medical Faculty. “neffy adjustments the paradigm in the case of remedy choices for sufferers and households dwelling with extreme allergic reactions — and the way in which wherein healthcare suppliers apply. Epinephrine auto-injectors have needles and this may be intimidating for sufferers. This may result in hesitancy in carrying and in utilizing the life-saving units, and sometimes ends in sufferers failing to deal with earlier than in search of emergency medical help. neffy gives a quick, easy-to-carry, easy-to-administer different that we anticipate will end in extra individuals carrying their epinephrine system and treating their allergic occasion earlier. These adjustments are prone to result in higher medical outcomes and fewer want for emergency room visits.”

“Years of dedication from the whole allergy neighborhood and healthcare suppliers have paved the way in which for neffy as the primary needle-free epinephrine remedy for extreme allergy symptoms,” stated Richard Lowenthal, Co-Founder, President, and CEO of ARS Prescription drugs. “We’re so pleased with our group members who’ve labored diligently from conception by FDA approval to make neffy obtainable. Now that individuals can start utilizing neffy, we’re wanting ahead to seeing the way it positively impacts as much as 40 million individuals within the U.S. who expertise extreme allergic reactions.”

Increasing Entry in Europe, Pediatric Indications

Along with its U.S. launch, ARS Prescription drugs plans to broaden entry to EURneffy^® (commerce identify for neffy within the EU) internationally in partnership with an EU-based pharmaceutical associate. On August 22, 2024, the European Fee permitted EURneffy (adrenaline nasal spray) for the emergency remedy of allergic reactions (anaphylaxis) within the EU. The corporate expects EURneffy to be obtainable in sure EU Member States by This autumn 2024.

ARS Prescription drugs has additionally submitted a supplemental New Drug Software (sNDA) to the FDA for the usage of neffy 1 mg in pediatric sufferers weighing 15 to 30 kg (33 to 66 lbs.), additional broadening its potential to guard susceptible populations from extreme allergic reactions.

About Kind I Allergic Reactions together with Anaphylaxis 

Kind I extreme allergic reactions are critical 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 remedy for these reactions. Whereas epinephrine auto-injectors have been proven to be extremely efficient, there are nicely printed limitations that end in many sufferers and caregivers delaying or not administering remedy in an emergency state of affairs. These limitations embody concern 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 america who expertise Kind I extreme allergic reactions attributable to meals, venom or insect stings. Of these, solely 3.3 million presently have an 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 system when wanted in an emergency.

About neffy®

neffy® is an intranasal epinephrine product for sufferers with Kind 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 remedy of Kind I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers who weigh 30 kg or larger.

IMPORTANT SAFETY INFORMATION

It’s endorsed 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.

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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 circumstances.

Administer with warning to sufferers who’ve coronary heart illness; epinephrine could 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 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 allergy symptoms, despair, thyroid problems, diabetes, and hypertension, could also be at larger threat for adversarial 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 circumstances, together with aged sufferers and pregnant girls.

Hostile 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 usually are not all the attainable uncomfortable side effects of neffy. To report suspected adversarial 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 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 extreme 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 US for emergency remedy 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 remedy of allergic reactions (anaphylaxis) attributable to 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” throughout the that means of the Non-public Securities Litigation Reform Act of 1995. These statements embody however usually are not restricted to: the platforms by which neffy will probably be accessible, together with BlinkRx; neffy, neffy.com, and neffyConnect’s potential advantages to sufferers and caregivers; the needle-free profile of neffy probably rising the chance that sufferers could each carry and administer epinephrine; the potential market and demand for neffy; the timelines for commercialization of EURneffy within the European Union; ARS Prescription drugs’s advertising and marketing and commercialization methods, together with potential partnerships in overseas jurisdictions; and different statements that aren’t historic truth. 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 equivalent to “can,” “might,” “expects,” “seemingly,” “could,” “plans,” “potential,” “will,” and comparable expressions are meant to establish forward-looking statements. These forward-looking statements are primarily based upon ARS Prescription drugs’s present expectations and contain assumptions which 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 on account of numerous dangers and uncertainties, which embody, with out limitation: the flexibility to acquire and preserve regulatory approval for neffy; potential security and different problems from neffy; the labelling for neffy in any future indication or affected person inhabitants, if permitted; 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 Prescription drugs’s means to guard its mental property place; and 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 “Threat Components” in ARS Prescription drugs’s Quarterly Report on Type 10-Q for the quarter ended June 30, 2024, filed with the Securities and Alternate Fee (SEC) on August 6, 2024. This and different paperwork ARS Prescription drugs recordsdata with the SEC can be accessed on ARS Prescription drugs’s web site at ir.ars-pharma.com by clicking on the hyperlink “Financials & Filings” underneath the “Traders & Media” tab.