Shots:
- Inconsistent access to epinephrine auto-injectors continues to be a major unmet need in the management of anaphylaxis
- neffy, an innovative intranasal epinephrine spray, provides a needle-free alternative for the emergency treatment of severe allergic reactions, including anaphylaxis, in adults and children aged four years and older who weigh at least 33 lbs
- Richard Lowenthal, CEO, Co-Founder, and President of ARS Pharmaceuticals, discusses neffy’s launch strategy, market positioning, and expansion plans across the US and Europe with PharmaShots
Saurabh: Congratulations on the successful commercial rollout of neffy in the U.S. and Europe! Could you elaborate on the launch strategies in both regions?
Richard: The launch of neffy has progressed successfully, with the 2 mg dose introduced in September 2024 and the 1 mg dose following in May 2025. We have heard from healthcare providers (HCPs), patients and caregivers that they like the attributes of neffy – it’s needle free, small size so it can fit into your pocket, temperature stabile up to 122°F and has a long shelf life of 24-30 months based on the dose.
A pivotal component of our launch plan is our direct to consumer (DTC) campaign, which was implemented in two phases. It began in mid-May 2025 with connected TV (streaming) and followed by broadcast/linear TV in late June. Since its rollout, the campaign has significantly increased consumer awareness since, driving added awareness of neffy from a baseline of approximately 20% pre-campaign to 49% in late July 2025. This momentum was especially impactful during the back-to-school season, and we’re starting to really see its impact on prescriptions.
Our market research indicates that an important driver of these sales is how the drug is being prescribed. Over 9,700 health care providers (HCPs) have prescribed neffy to date, which represents a 73% increase from April 2025.This growth has been supported in part by our introduction of the 1 mg dosage in the U.S. in March of this year for pediatric patients weighing 15 to < 30 kilograms.
Insurance coverage has also played a vital role in our strategy. neffy’s access and approval rates across the major pharmacy benefit managers (PBMs) have been consistent with the overall epinephrine market, exceeding our expectations for patient access to the treatment.
Internationally, we’ve achieved a major milestone with the approval of EURneffy in the EU and U.K., as the first needle-free adrenaline treatment. Our partner ALK-Abelló has launched EURneffy in Germany in June 2025 with plans to launch in the U.K. later this year.
Saurabh: Please shed some light on the neffy Experience Program and neffyinSchools program.
Richard: In the neffy experience program, healthcare providers are given six doses of neffy for use to treat patients experiencing anaphylaxis symptoms during oral food challenge or allergen immunotherapy. Approximately 2,800 allergists have enrolled in the neffy Experience Program, with about 20,000 doses, across both neffy 2 mg and 1 mg, distributed as part of this program. First large-scale real-world analysis of neffy treatment outcomes during routine clinical practice. Over 500 patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy were treated by healthcare providers and nearly 90% (89.2%) were successfully treated with a single dose of neffy. Existing research on epinephrine intramuscular injection or auto-injector reports 88.9% of patients being successfully treated with a single dose administered by a healthcare provider for food-induced anaphylaxis – illustrating highly similar treatment success rates.
Our neffyinSchools provides eligible public and private K-12 schools in the U.S. with the opportunity to receive two cartons (four single use doses) of neffy for use in emergency situations at no cost to the school via the School Health Corp. SHConnect platform. More than 5,900 schools have opted into the neffyinSchools program across 23 states.
Saurabh: What’s the secret sauce behind the exceeding commercial coverage (93% with approximately 58% without prior authorization) in the U.S.?
Richard: A key driver of our growth and momentum has been achieving a critical milestone in payor access, which has meaningfully reduced administrative barriers for healthcare providers. As neffy’s prescription volume continues to increase, we anticipate that the economic factors for the remaining pharmacy benefit managers (PBMs) will continue to reduce prior authorization requirements.
Additionally, our strong sales force execution, combined with the impact of our direct-to-consumer (DTC) advertising, positions us well for continued market share growth. This, along with a more seamless HCP prescribing experience and enhanced consumer awareness, creates a strong foundation for continued commercial expansion.
ARS remains actively engaged with insurers to cover neffy without any restrictions. neffy is the first innovation in epinephrine in decades; and patients certainly deserve the opportunity to have choice in the epinephrine device they’d like to carry and not be restricted.
Saurabh: What challenges did ARS face in neffy’s commercial launch in the U.S., and what strategies did you employ to overcome those hurdles?
Richard: One of the most significant challenges we’ve faced with the U.S. launch of neffy has been the realities of limited bandwidth of physicians. This is especially true among allergists and pediatricians who are extremely busy, particularly during the summer months leading up to the school year. With a limited number of physicians serving millions of patients, it can be difficult for clinicians to find the time to introduce and transition patients to a new treatment.
To help address this, we’ve prioritized empowering patients and caregivers through easily accessible online resources and educational tools about neffy. We’ve also launched a DTC campaign and strengthened partnerships with leading advocacy organizations like FARE, supporting public awareness initiatives and efforts to improve insurance coverage for innovative treatments like neffy.
Saurabh: What is the timeline for neffy’s approval in Canada, Japan, Australia, and China?
Richard: Regulatory approvals for neffy in Canada (with ALK-Abelló), Japan (in partnership with Alfresa), and Australia (in partnership with CSL), are expected before the end of 2025, with commercial rollouts planned in the first half of 2026. Regulatory approval for neffy in China (in partnership with Pediatrix) is expected in the first half of 2026.
Saurabh: Could you highlight the clinical data from the trials evaluating intranasal epinephrine technology as a treatment for acute flares in chronic spontaneous urticaria?
Richard: The Phase 2 trial successfully met its primary endpoints, with both the2 mg and 1 mg doses of neffy demonstrating clinically meaningful improvements in itch, hives and erythema scores as early as five minutes after dosing. Urticaria is a skin disorder that causes itchy hives, rashes, and/or angioedema; notably, 50% of chronic urticaria cases are non-responsive to first-line antihistamine therapy.
In June 2025, ARS Pharma initiated a Phase 2b clinical trial to evaluate its intranasal epinephrine technology as a treatment for acute flares in patients with chronic spontaneous urticaria (hives). The trial is currently enrolling patients in the U.S. and Europe, with topline data anticipated in the first half of 2026. This program expansion represents a significant opportunity to extend the utility of the company’s intranasal epinephrine technology to a new indication that affects approximately two million people in the U.S. alone.
About the Author:
Richard Lowenthal, M.S., MSEL
Richard Lowenthal, M.S., MSEL, is the CEO, Co-Founder, President, and a board member at ARS Pharmaceuticals. He also served as the company’s Chairman from 2015 through 2018 and has served as ARS’ Chief Executive Officer since 2018. Mr. Lowenthal previously served as President of Pacific-Link Regulatory Consulting and Research, Inc., a medicinal product development consultancy. Mr. Lowenthal held many leadership roles at several biopharmaceutical and pharmaceutical companies that included Chief Executive Officer and President of MTG Biotherapeutics.
Related Post: Optimizing Life Sciences CRM: A Candid Conversation with Akshay Kapadia from Conexus Solutions
