Sufferers can request a prescription from their present healthcare supplier, or meet with a doctor nearly, to request a prescription for neffy forward of product availability anticipated by late September
Go to neffy.com to pre-order and entry complete affected person help packages obtainable to sufferers and caregivers
Sufferers who have already got a prescription can work with their healthcare supplier to request neffy via the neffyConnect service and BlinkRx
SAN DIEGO, Sept. 04, 2024 (GLOBE NEWSWIRE) — ARS Prescription drugs, Inc. (Nasdaq: SPRY), a biopharmaceutical firm devoted to empowering at-risk sufferers and their caregivers to higher defend sufferers from extreme allergic reactions that would result in anaphylaxis, introduced at present pre-ordering companies for neffy® (epinephrine nasal spray), making certain swift entry upon availability, anticipated in late September. Not too long ago, the U.S. Meals and Drug Administration (FDA) authorized neffy for the remedy of Sort I Allergic Reactions, together with anaphylaxis, in adults and kids who weigh ≥30 kg (66 lbs.). Pre-ordering can start instantly through neffy.com.
“Folks with extreme allergic reactions have been ready for a needle-free epinephrine choice, which is why we now have prioritized a variety of help packages, together with the launch of at present’s pre-ordering service,” stated Richard Lowenthal, Co-Founder, President and CEO of ARS Prescription drugs. “Now, sufferers can work with their healthcare supplier or have a digital session with a doctor to acquire a prescription for neffy and get it shipped on to their houses in as little as two days following availability within the U.S. One main benefit of ordering via neffy.com, for sufferers and healthcare suppliers, is that ARS Prescription drugs will have the ability to assist with prior authorization from insurance coverage firms, so many sufferers may have a co-pay as little as $25 for 2 single-use neffy units.”
Prioritizing Affected person Entry
By visiting neffy.com sufferers can choose the “Get neffy now” button for easy and quick entry to acquire a prescription for neffy. Sufferers can be provided two choices, the place they will request a prescription from their present healthcare supplier, or they will entry a doctor via a digital session. Each choices will assist with navigating prior authorization and insurance coverage questions via the neffyConnect service.
For healthcare suppliers, the neffyConnect service and on-line pharmacy, BlinkRx, is already accepting prescriptions for neffy, to make sure sufferers and caregivers can start carrying neffy as quickly as it’s obtainable. By BlinkRx, sufferers can be shipped neffy freed from cost. neffy is anticipated to be obtainable through BlinkRx and at retail pharmacies nationwide by late September.
As a further useful resource, neffyConnect can information sufferers and caregivers via matters similar to copay financial savings, insurance coverage protection help, at-home supply choices, refill reminders and figuring out reasonably priced pricing.
For sufferers who’ve industrial insurance coverage, ARS Prescription drugs is dedicated to limiting what eligible commercially insured sufferers pay to simply $25 for every crammed prescription of two single-use neffy units through a co-pay financial savings program. For eligible sufferers with out insurance coverage protection, conditions through which a well being plan doesn’t but cowl neffy, or if a affected person faces excessive out-of-pocket prices as a result of a high-deductible plan, ARS Prescription drugs is providing a money value of $199 for 2 doses of neffy.
As well as, for eligible U.S. residents who’re uninsured or underinsured, meet sure eligibility standards, and have exhausted all different choices, the ARS Prescription drugs Affected person Help Program (PAP) will present neffy without charge.
“From the angle of somebody who’s each a clinician and a meals allergy affected person, having an alternative choice for epinephrine supply is essential. Fast administration of epinephrine is essential to managing anaphylaxis and decreasing injection hesitancy performs a necessary position in making certain well timed remedy. We’re happy that sufferers will quickly have the ability to entry an alternative choice for his or her epinephrine supply,” stated Sung Poblete, PhD, RN, CEO of FARE (Meals Allergy Analysis and Training), a non-profit group devoted to meals allergy consciousness and advocacy.
About Sort I Allergic Reactions together with Anaphylaxis
Sort I extreme allergic reactions are critical and doubtlessly life-threatening occasions that may happen inside minutes of publicity to an allergen and require instant remedy with epinephrine, the one FDA-approved treatment for these reactions. Whereas epinephrine auto-injectors have been proven to be extremely efficient, there are effectively revealed limitations that lead to 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 issues, lack of reliability, and complexity of the units. There are roughly 40 million individuals in the US who expertise Sort I extreme allergic reactions as a result of meals, venom or insect stings. Of these, solely 3.3 million presently have an energetic 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 machine when wanted in an emergency.
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 remedy of sort 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 instant entry to 2 neffy nasal sprays always. Within the absence of scientific 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 circumstances.
Administer with warning to sufferers who’ve coronary heart illness; epinephrine might irritate 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 circumstances or who take sure medicines for allergic reactions, melancholy, thyroid issues, diabetes, and hypertension, could also be at larger danger for opposed reactions.
Epinephrine can quickly exacerbate the underlying situation or improve signs in sufferers with the next: hyperthyroidism, Parkinson’s illness, diabetes, renal impairment. Epinephrine ought to be administered with warning in sufferers with these circumstances, together with aged sufferers and pregnant girls.
Antagonistic 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 are usually not all the potential unintended effects of neffy. To report suspected opposed 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 info on neffy, please see Full Prescribing Info at www.neffy.com.
About ARS Prescription drugs, Inc.
ARS Pharma is a biopharmaceutical firm devoted to empowering at-risk sufferers and their caregivers to higher defend sufferers from extreme allergic reactions that would result in anaphylaxis. The Firm is commercializing neffy® (commerce identify EURneffy within the EU) (beforehand known as ARS-1), an epinephrine nasal spray for sufferers with Sort I allergic reactions together with meals, medicines and bug bites that would result in life-threatening anaphylaxis. 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” throughout the that means of the Non-public Securities Litigation Reform Act of 1995. These statements embody however are usually not restricted to: the timeline for neffy’s industrial availability; neffy and neffy.com’s potential advantages to sufferers and caregivers; costs at which ARS Pharma plans to make neffy commercially obtainable; the platforms via which neffy can be accessible, together with BlinkRx; the needle-free profile of neffy doubtlessly growing the probability that sufferers might each carry and administer adrenaline; the potential market and demand for neffy; and different statements that aren’t historic reality. 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 similar to “can,” “may,” “expects,” “potential,” “will,” and related expressions are meant to determine forward-looking statements. These forward-looking statements are primarily based upon ARS Pharma’s 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 because of varied dangers and uncertainties, which embody, with out limitation: the power to acquire and keep regulatory approval for neffy; potential security and different problems from neffy; the labelling for neffy in any future indication or affected person inhabitants, if authorized; the scope, progress and enlargement of creating and commercializing neffy; the potential for payors to delay, restrict or deny protection for neffy; the scale and progress of the market therefor and the speed and diploma of market acceptance thereof vis-à-vis intramuscular injectable merchandise; ARS Pharma’s potential 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 “Danger Components” in ARS Pharma’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 Pharma information with the SEC can be accessed on ARS Pharma’s web site at ir.ars-pharma.com by clicking on the hyperlink “Financials & Filings” underneath the “Buyers & Media” tab.
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
