Bryn Pharma is developing an epinephrine auto-injector alternative administered via an intranasal delivery system
We know that:
- The vast majority of patients at risk for anaphylaxis do not carry their auto-injectors on a regular basis
- Approximately 35% of those diagnosed carry only one auto-injector
- Approximately 5% of those diagnosed carry the recommended two auto-injectors
- Patients/Caregivers are afraid to inject themselves because of the needle causing delay in treatment
- Patients/Caregivers don’t carry the auto-injectors because they are too big
Our vision is to create a practical solution to help our community to better manage their daily lives with severe allergies
Our Regulatory Approach
Bryn Pharma is pursuing a 505(b)(2) NDA path by comparing the Bryn Pharma product in a Pivotal Clinical Trial against the Reference Listed Drug (EpiPen™, NDA 019430, Mylan Inc.). In early 2019, Bryn submitted an Investigational New Drug (IND) application with the FDA to treat patients with life-threatening allergic reactions that could lead to anaphylaxis. Bryn’s developmental program was granted Fast Track Designation by the FDA in February 2019.
Check back for updates on our regulatory progress.
Bryn Pharma has completed 7 comprehensive, pre-clinical studies prior to designing its clinical studies in humans.
Bryn Pharma conducted a pilot study in humans in April 2019. The results of the pilot clinical study demonstrated that the intranasal delivery of epinephrine had comparable pharmacokinetics to an intramuscular injection of epinephrine, was safe, and had a favorable tolerability profile. Bryn is currently conducting its Pivotal Clinical Trial.