Bryn Pharma

Bryn Pharma is a privately held pharmaceutical company, established in 2017 and headquartered in Raleigh, North Carolina, focused on the market for anaphylaxis treatment. The company's creation was driven by personal experience; co-founder Michelle Lobel, who has severe nut allergies and is a mother to two children with the same condition, was motivated to find a better alternative to traditional epinephrine auto-injectors. Her journey began from a personal need, questioning why the bulky and needle-based devices hadn't seen the same user-centric evolution as consumer technology. This led to the founding of Bryn Pharma with Steven Hartman, aiming to develop a more patient-friendly solution.

The company is in the late stages of developing UTULY™, an intranasal epinephrine spray designed to be a needle-free, portable, and easy-to-use alternative for treating life-threatening allergic reactions. The product, which utilizes Aptar Pharma's Bidose (BDS) nasal delivery device, is designed to deliver two therapeutic doses of epinephrine from a single, pocket-sized unit. This addresses key limitations of current auto-injectors, such as needle phobia, which can delay administration, and the inconvenience of carrying the recommended two devices. The target market includes a growing population of patients at risk for anaphylaxis who may avoid carrying or using current devices due to these drawbacks.

Bryn Pharma's business model centers on the development, regulatory approval, and commercialization of UTULY™. The company has successfully raised significant capital to fund these efforts, securing a total of $123 million over five funding rounds from investors including Chazen Capital Partners and RezVen Partners. The company has completed pivotal clinical trials comparing UTULY™ to the standard 0.3 mg epinephrine auto-injector. Results presented at medical conferences indicated that UTULY™ demonstrated a comparable safety profile and achieved therapeutic epinephrine levels rapidly, which were sustained longer than those from the auto-injector. Following positive Phase 3 trial results, Bryn Pharma has been preparing for a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which had granted the product Fast Track Designation.

Keywords: Anaphylaxis treatment, epinephrine nasal spray, needle-free epinephrine, UTULY, allergy emergency medicine, Bryn Pharma, Michelle Lobel, pharmaceutical development, bi-dose delivery system, Aptar Pharma, severe allergies, food allergy, life-threatening allergies, epinephrine alternative, auto-injector replacement, intranasal drug delivery, clinical trials, FDA submission, patient-centric design, portable medical device