Bryn Pharma has dosed the first participant in a clinical trial evaluating its second-generation epinephrine nasal spray, marking a significant milestone in the development of needle-free anaphylaxis treatment. The study focuses on an innovative dual-dose profile that could address critical gaps in current emergency care by delivering two complete therapeutic doses from a single, lip-balm sized device.
Novel Dual-Dose Technology Addresses Treatment Barriers
The clinical trial evaluates Bryn's upgraded two-spray nasal spray device, which incorporates several enhancements over previous versions including wider finger flanges for easier handling, a tapered nozzle to improve comfort and fit, and an integrated dose indicator for clear user feedback. The dual-dose profile represents a potential breakthrough in anaphylaxis care, as current treatment options require patients to carry two separate devices at all times due to the significant risk that one dose may not fully resolve symptoms.
"This trial also provides the exciting opportunity to evaluate our innovative dual-dose profile, which has the potential to revolutionize anaphylaxis care by delivering two complete therapeutic doses in a single, lip-balm sized nasal spray," said Joshua Ziel, Chief Executive Officer of Bryn Pharma.
Trial Design and Regulatory Recognition
The study employs a two-cohort design to comprehensively evaluate the nasal spray's performance. Cohort 1 will assess the dual-dose profile, with participants receiving a single-spray dose for pharmacokinetic, pharmacodynamic, and safety comparisons to injectable epinephrine standards of care. Cohort 2 will evaluate a double-spray dose from the nasal spray device versus injectable epinephrine across the same parameters.
Bryn's innovative approach has received Fast Track designation from the U.S. Food and Drug Administration, which is granted to facilitate development and expedite review of drugs addressing unmet medical needs in serious conditions. This recognition underscores the significant potential of the needle-free epinephrine delivery system to transform emergency anaphylaxis care.
Addressing Critical Unmet Medical Need
The anaphylaxis treatment landscape reveals substantial barriers to optimal care. More than 50% of patients prescribed autoinjectors do not carry or use them as recommended due to needle phobia, accessibility issues, and portability challenges. The incidence of severe allergic reactions and anaphylaxis risk continues to rise dramatically across both children and adults, yet the gold-standard treatment has remained largely unchanged since epinephrine autoinjectors were introduced in 1987.
Each Bryn nasal spray device is designed to achieve higher therapeutic epinephrine levels than the current gold-standard 0.3 mg epinephrine autoinjector. The program builds on a proven active ingredient and device platform, benefiting from the streamlined 505(b)(2) regulatory pathway in the United States.
Clinical Development Progress
Results from this trial will add to substantial clinical evidence for Bryn's epinephrine nasal spray program, which includes completion of four pivotal clinical trials with the nasal spray platform and proprietary formulation. Data readout from the current trial is expected in Q3 2025.
The company's epinephrine nasal spray program combines a proprietary epinephrine formulation with a unique two-spray nasal delivery system, designed to provide patients at risk for anaphylaxis with a portable, convenient, and accessible treatment option that addresses pent-up demand for needle-free alternatives.
