Bringing New Delivery Methods to Treatments: Q&A with Richard Lowenthal

In March 2025, FDA approved ARS Pharmaceutical’s neffy, an epinephrine nasal spray used to treat type 1 allergic reactions. At the time, the company celebrated the approval and called it the first major advancement for the medicine in over 35 years.

Richard Lowenthal, CEO of ARS, specifically pointed out how bringing a needle-free option to the market would provide numerous benefits, especially when providing treatment to children. Lowenthal recently connected with Pharmaceutical Executive to discuss the current state of drug reformulation and updating delivery design.

According to him, the way that a drug is delivered can have a significant impact on whether patients actually take the medicine. Often, these patients end up delaying necessary treatment, which can have significant consequences.

Pharmaceutical Executive: Can reformulating drugs compete with first-in-class therapies?
Richard Lowenthal: Reformulating drugs can certainly compete with first‑in‑class therapies, particularly when reformulation addresses the real‑world barriers that prevent patients from effective treatment. For decades, epinephrine was only available for community use in auto‑injector form, which left a significant treatment gap. Many patients hesitate to use auto-injectors because of the needle, struggle with device complexity, or simply do not carry their auto-injectors consistently because they’re bulky and don’t fit easily it a pocket. That unmet need is what inspired neffy® (epinephrine nasal spray), the first meaningful innovation in epinephrine delivery in over 35 years.

At ARS Pharma, we saw an opportunity to rethink how life‑saving medicine is delivered in an emergency. neffy was designed to address the challenges patients and caregivers face—including needle anxiety, difficulty using injection devices, and limitations around portability and storage. By removing these barriers, neffy helps people carry epinephrine more consistently and act with greater confidence at the first signs of symptoms.

In emergency situations, speed, simplicity, and confidence of use are just as important as the medicine itself. Reformulation that improves portability, ease of administration, and reliability can directly determine whether treatment is given at all. Where we see the greatest benefit with neffy is reducing hesitation resulting in faster action that prevents symptoms of anaphylaxis progressing. Reformulated medicines can compete head‑to‑head with first‑in‑class therapies, and in some cases deliver even greater real‑world impact when they successfully address the issues patients face with the existing treatment.

We’re encouraged by the growing body of real‑world evidence supporting neffy. One real‑world data study published in the American College of Allergy, Asthma and Immunology (ACAAI) found that about nine out of ten patients experiencing anaphylaxis were effectively treated with a single dose of neffy – that’s consistent with what has been reported for rates of effectiveness with epinephrine auto‑injectors. For us, this reinforces that patients are getting the same effective epinephrine that they are accustomed to, but in an innovative, less invasive device that’s helping close a long‑standing gap in severe allergy care.

PE: How does delivery design transform real life outcomes?
Lowenthal: Delivery design plays a critical role in whether life‑saving treatment is actually used during an emergency. Despite the clear link between early epinephrine use and better outcomes, research shows that approximately 40% of people delay treatment,1 and 56% of caregivers fear using needle-based auto-injectors on their child.2

At ARS Pharma, we’ve always believed these medicines must be designed around the patient and the real‑world situations they face. That belief is what led to neffy, as we recognized that needles and complex delivery systems can introduce hesitation, increase anxiety, and raise the risk of user error – especially in high‑stress moments like an anaphylactic reaction.

In an emergency, every second matters, and delays in treatment can have serious consequences. Designing delivery systems that are intuitive and easy to use can make the difference between life and death.

This is why delivery innovation matters so much. Patients want options that fit into their daily lives – treatments that are easy to carry, easy to use, and ready when needed. Our findings reinforce a preference for needle‑free, user‑friendly treatment like neffy, which are designed to reduce barriers and support faster, more confident treatment in real‑world settings.

PE: Where is innovation in emergency medicine heading next?
Lowenthal: Innovation in emergency medicine is increasingly focused on getting life‑saving treatment to patients earlier and in more settings – not just on discovering new drugs. We’re seeing a shift away from complex dosing and injection‑based administration toward simpler, needle‑free, easy‑to‑use delivery formats that reduce hesitation in emergencies. I think we’re going to see more products in the future designed to be administered quickly and confidently––not only by first responders and caregivers, but by patients themselves.

The success of nasal spray emergency medications like Narcan demonstrated that usability and speed can be just as life‑saving as the medicine itself. The next phase of innovation is about removing friction between symptom onset and treatment, bringing emergency therapies into homes, schools, and community settings so care can begin before emergency departments are involved.

Access is also a critical part of innovation. Through programs like neffyinSchools, eligible schools can apply to receive neffy at no cost, helping ensure they’re prepared to respond to allergic emergencies with a needle‑free option. Initiatives like this reflect our broader mission at ARS Pharma: to expand access and make life‑saving treatment available wherever it’s needed. Many children experience their first severe allergic reaction at school – we want families to have greater confidence and peace of mind that their child will be safe and treated promptly if there’s an emergency at school.

PE: What impact did bringing Narcan to the market have on emergency care?
Lowenthal: Narcan fundamentally changed emergency care by moving overdose response from a setting that required medical professionals to one that could happen immediately, wherever the patient is. By introducing a nasal spray formulation, Narcan made it possible for non‑medical individuals to administer life‑saving treatment quickly and safely in the community setting. That shift dramatically reduced time to intervention.

More broadly, Narcan helped redefine what emergency responses can look like. It normalized overdose reversal as an early, front‑line intervention rather than a last‑step clinical procedure. In doing so, it helped prevent fatal outcomes and eased pressure on emergency departments. Narcan didn’t just introduce a new formulation – it changed expectations around who can act, how quickly they can act, and where emergency care can begin.

Making life‑saving treatment more accessible, intuitive, and ready for real‑world use helped inspire a new generation of emergency therapies, including neffy.

PE: What are the benefits of needle-free treatments?
Lowenthal: Needle‑free treatments address some of the most common barriers that prevent people from using life‑saving medications in an emergency, including ease of use, portability, and fear of administration. We know that many people hesitate or delay using epinephrine during an allergic reaction, and that hesitation can lead to serious consequences. At ARS Pharma, our focus has always been on closing that gap by making epinephrine easier to use - especially for our littles patients. We know children, and their parents, dislike having to inject a needle and we have received many testimonials stating nasal spray has been life changing for their family.

Beyond being needle‑free, neffy is designed for real‑world living. Unlike auto‑injectors, it’s travel‑ready, with temperature flexibility that allows it to withstand heat up to 122°F for a few days as well as cold conditions - neffy can be used once fully thawed if accidentally frozen. neffy also offers a longer shelf life, up to 2.5 years for the 2 mg dose, reducing the burden of frequent replacement. Its small, compact design makes it easier to keep with you at all times.

Together, these features reflect a broader shift in drug delivery, where innovation is about removing barriers so life-saving treatment is easier to carry, easier to use and more likely to be used when it matters most in addition to being about the medicine itself.

Sources

1. Sheikh A, Dhami S, Regent L, Austin M, Sheikh A. Anaphylaxis in the community: a questionnaire survey of members of the UK Anaphylaxis Campaign. JRSM Open. 2015 Jul 28;6(7):2054270415593443. doi: 10.1177/2054270415593443
2. Chad L, Ben-Shoshan M, Asai Y, et al. A majority of parents of children with peanut allergy fear using the epinephrine auto-injector. Allergy. 2013;68(12):1605-1609. https://doi.org/10.1111/all.12262.