Bryn Pharma is developing an affordable, needle-free, small, easy to use epinephrine nasal spray as an alternative to current epinephrine autoinjectors for the treatment of anaphylaxis. Our clinical program focused on efficacy and safety comparisons of UTULY™ to the current standard of care treatment, the 0.3 mg IM autoinjector, in accordance with clinical practice guidelines.

Bryn is addressing current treatment gaps in Anaphylaxis:

  • Most patients at risk for anaphylaxis do not carry their autoinjectors on a regular basis
  • One of the main reasons that patients/caregivers don’t carry the autoinjectors is because they are too big and bulky
  • Even for those patients that carry their device, they often are afraid to inject themselves because of the anxiety, stress and fear of the needle, causing delay in treatment1

Our Science

The results have demonstrated that with a single dose of UTULY, its PK release profile is comparable to the standard reference product, the 0.3 mg IM autoinjector, and a more rapid uptake than the manual syringe, especially in the critical acute phase of an anaphylactic event, i.e., the first 20-minutes. In addition, the data clearly demonstrate that UTULY™ is safe: across the entire clinical development program, there have been no serious or unexpected adverse events.

Our Regulatory Approach

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. Bryn Pharma is pursuing a 505(b)(2) NDA path by comparing UTULY™ in a Pivotal Clinical Trial against the reference listed drug, the 0.3 mg IM autoinjector.