ARS Pharmaceuticals Launches Pre-Ordering Services for neffy® to Help Patients Access the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis

Rhea-AI Summary

ARS Pharmaceuticals (Nasdaq: SPRY) has launched pre-ordering services for neffy®, the first FDA-approved needle-free epinephrine nasal spray for Type I Allergic Reactions, including anaphylaxis. Patients can now pre-order neffy through neffy.com, with availability expected by late September. The company offers two options for obtaining prescriptions: through existing healthcare providers or virtual physician consultations.

ARS Pharmaceuticals is prioritizing patient access with comprehensive support programs, including:

• neffyConnect service for insurance navigation and prior authorization assistance
• Co-pay savings program limiting costs to $25 for eligible commercially insured patients
• Cash price of $199 for two doses for eligible patients without coverage
• Patient Assistance Program (PAP) providing neffy at no cost for eligible uninsured or underinsured patients

The company aims to address injection hesitancy and ensure timely treatment of anaphylaxis with this new delivery option.

Positive

• FDA approval of neffy® as the first needle-free epinephrine nasal spray for Type I Allergic Reactions
• Pre-ordering services launched to ensure swift access upon availability
• Comprehensive patient support programs including co-pay savings and assistance for uninsured patients
• Potential to address injection hesitancy and improve timely treatment of anaphylaxis

Negative

• Product not yet available, with expected launch in late September
• to patients weighing ≥30 kg (66 lbs.)

Insights

Medical Research Analyst

The launch of neffy®, the first needle-free epinephrine nasal spray for Type I Allergic Reactions, marks a significant advancement in anaphylaxis treatment. This FDA-approved alternative addresses a important need in allergy management, potentially improving patient compliance and reducing hesitation in emergency situations. The pre-ordering system and comprehensive patient assistance programs demonstrate ARS Pharmaceuticals' commitment to accessibility.

The $25 co-pay for commercially insured patients and $199 cash price for two doses are competitive, potentially disrupting the current epinephrine auto-injector market. However, the long-term impact on patient outcomes and market share remains to be seen, as real-world data on efficacy and ease of use will be critical. The late September availability aligns with the back-to-school season, a strategic timing for allergy-related products.

Financial Analyst

ARS Pharmaceuticals' (NASDAQ: SPRY) launch of neffy® pre-ordering services is a strategic move that could positively impact the company's financial outlook. The innovative needle-free delivery system addresses a $2 billion market for epinephrine products. The company's focus on accessibility, including the $25 co-pay program and $199 cash price, could drive rapid adoption and market penetration.

Investors should monitor initial sales figures and prescription trends following the late September release. The partnership with BlinkRx for direct-to-patient shipping could streamline distribution and potentially improve margins. However, the impact on the company's burn rate and path to profitability needs careful consideration. The stock may see increased volatility as the market assesses neffy®'s commercial success in the coming quarters.

Market Research Analyst

The launch of neffy® represents a potential paradigm shift in the allergic reaction treatment market. ARS Pharmaceuticals is positioning the product strategically with its pre-ordering system and patient assistance programs, addressing key barriers to adoption such as cost and accessibility. The needle-free design could significantly expand the market by appealing to needle-phobic patients and caregivers, potentially increasing overall epinephrine use in emergencies.

Market acceptance will likely hinge on education and awareness campaigns, as well as real-world effectiveness data. The endorsement from FARE (Food Allergy Research and Education) lends credibility and could accelerate adoption within the food allergy community. Competitors in the epinephrine auto-injector space may need to innovate or adjust pricing strategies in response to neffy®'s entry, potentially leading to increased market dynamics and price competition.

Patients can request a prescription from their existing healthcare provider, or meet with a physician virtually, to request a prescription for neffy ahead of product availability expected by late September

Visit neffy.com to pre-order and access comprehensive patient assistance programs available to patients and caregivers

Patients who already have a prescription can work with their healthcare provider to request neffy through the neffyConnect service and BlinkRx

SAN DIEGO, Sept. 04, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today pre-ordering services for neffy^® (epinephrine nasal spray), ensuring swift access upon availability, expected in late September. Recently, the U.S. Food and Drug Administration (FDA) approved neffy for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). Pre-ordering can begin immediately via neffy.com.

“People with severe allergies have been waiting for a needle-free epinephrine option, which is why we have prioritized a number of support programs, including the launch of today’s pre-ordering service,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharmaceuticals. “Now, patients can work with their healthcare provider or have a virtual consultation with a physician to obtain a prescription for neffy and get it shipped directly to their homes in as little as two days following availability in the U.S. One major advantage of ordering through neffy.com, for patients and healthcare providers, is that ARS Pharmaceuticals will be able to help with prior authorization from insurance companies, so many patients could have a co-pay as low as $25 for two single-use neffy devices.”

Prioritizing Patient Access
By visiting neffy.com patients can select the “Get neffy now” button for simple and fast access to obtain a prescription for neffy. Patients will be offered two options, where they can request a prescription from their existing healthcare provider, or they can access a physician through a virtual consultation. Both options will help with navigating prior authorization and insurance questions through the neffyConnect service.

For healthcare providers, the neffyConnect service and online pharmacy, BlinkRx, is already accepting prescriptions for neffy, to ensure patients and caregivers can begin carrying neffy as soon as it is available. Through BlinkRx, patients will be shipped neffy free of charge. neffy is expected to be available via BlinkRx and at retail pharmacies nationwide by late September.

As an additional resource, neffyConnect can guide patients and caregivers through topics such as copay savings, insurance coverage support, at-home delivery options, refill reminders and identifying affordable pricing.

For patients who have commercial insurance, ARS Pharmaceuticals is committed to limiting what eligible commercially insured patients pay to just $25 for each filled prescription of two single-use neffy devices via a co-pay savings program. For eligible patients without insurance coverage, situations in which a health plan does not yet cover neffy, or if a patient faces high out-of-pocket costs due to a high-deductible plan, ARS Pharmaceuticals is offering a cash price of $199 for two doses of neffy.

In addition, for eligible U.S. residents who are uninsured or underinsured, meet certain eligibility criteria, and have exhausted all other options, the ARS Pharmaceuticals Patient Assistance Program (PAP) will provide neffy at no cost.

"From the perspective of someone who is both a clinician and a food allergy patient, having another option for epinephrine delivery is crucial. Quick administration of epinephrine is key to managing anaphylaxis and reducing injection hesitancy plays an essential role in ensuring timely treatment. We’re pleased that patients will soon be able to access another option for their epinephrine delivery," said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research and Education), a non-profit organization dedicated to food allergy awareness and advocacy.

About Type I Allergic Reactions including Anaphylaxis
Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I severe allergic reactions due to food, venom or insect stings. Of those, only 3.3 million currently have an active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.

About neffy^®

neffy^® is an intranasal epinephrine product for patients with Type I allergic reactions including food, medications, and insect bites that could lead to life-threatening anaphylaxis.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)

INDICATION

neffy 2 mg is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater.

IMPORTANT SAFETY INFORMATION

It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose.

neffy is for use in the nose only.

Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.

Absorption of neffy may be affected by underlying structural or anatomical nasal conditions.

Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.

The presence of a sulfite in neffy should not deter use.

neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy.

Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions.

Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.

Adverse reactions to neffy may include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.

These are not all of the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional information on neffy, please see Full Prescribing Information at www.neffy.com.

About ARS Pharmaceuticals, Inc.
ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy^® (trade name EURneffy in the EU) (previously referred to as ARS-1), an epinephrine nasal spray for patients with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis. For more information, visit www.ars-pharma.com.

Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include but are not limited to: the timeline for neffy’s commercial availability; neffy and neffy.com’s potential benefits to patients and caregivers; prices at which ARS Pharma plans to make neffy commercially available; the platforms through which neffy will be accessible, including BlinkRx; the needle-free profile of neffy potentially increasing the likelihood that patients may both carry and administer adrenaline; the potential market and demand for neffy; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “can,” “could,” “expects,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: the ability to obtain and maintain regulatory approval for neffy; potential safety and other complications from neffy; the labelling for neffy in any future indication or patient population, if approved; the scope, progress and expansion of developing and commercializing neffy; the potential for payors to delay, limit or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission (SEC) on August 6, 2024. This and other documents ARS Pharma files with the SEC can also be accessed on ARS Pharma’s website at ir.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.

ARS Investor Contact:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com

ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com

FAQ

When will neffy® (SPRY) be available for purchase?

neffy® is expected to be available via BlinkRx and at retail pharmacies nationwide by late September 2024.

How can patients pre-order neffy® (SPRY)?

Patients can pre-order neffy® by visiting neffy.com and selecting the 'Get neffy now' button to obtain a prescription through their existing healthcare provider or a virtual physician consultation.

What is the cost of neffy® (SPRY) for commercially insured patients?

ARS Pharmaceuticals offers a co-pay savings program limiting costs to $25 for each filled prescription of two single-use neffy devices for eligible commercially insured patients.

Is there a patient assistance program for neffy® (SPRY)?

Yes, ARS Pharmaceuticals offers a Patient Assistance Program (PAP) providing neffy® at no cost for eligible U.S. residents who are uninsured or underinsured and meet certain eligibility criteria.