Bryn Pharma, a privately held pharmaceutical company based in Raleigh NC, announced positive data regarding their intranasal epinephrine candidate named UTULY at this year’s annual AAAAI meeting in San Antonio TX.
UTULY is a needleless, self administered nasal spray intended to be used in anaphylactic emergencies in place of traditional 0.3mg auto-injectors which are jabbed into the outer thigh.
Some key data points presented include:
- UTULY 13.2mg showed rapid absorption and resulted in higher and more sustained therapeutic epinephrine plasma levels compared to 0.3mg autoinjector.
- The percentage of subjects reaching therapeutic plasma levels of epinephrine in the acute period post-dose with UTULY were comparable to or higher than seen with the 0.3mg autoinjector;
- When compared to the inpatient standard of care (0.5mg IM manual syringe), the study results showed that UTULY had a faster rate of absorption and a higher or comparable acute and overall exposure;
- The data support the ability of UTULY 13.2mg to achieve therapeutic levels of epinephrine rapidly and to maintain those levels essentially twice as long as those achieved using the 0.3mg IM autoinjector with a similar safety profile;
- There were no deaths, serious adverse events (SAEs), or laboratory-related events reported in this study. Overall, the safety results for UTULY and IM administration routes were comparable, demonstrating that UTULY was safe and well tolerated.
Said Dr David Dworaczyk, CEO of Bryn Pharma:
We were extremely pleased with the results achieved in this pivotal study, demonstrating that therapeutic levels of epinephrine were achieved as quickly and maintained those levels for essentially twice as long as those achieved using the current standard of care, 0.3mg IM autoinjector, with a similar safety profile. The rapid attainment and sustained level of therapeutic levels of epinephrine are critical to optimize the successful treatment of anaphylaxis. This is an exciting advance for UTULY, and especially for the patient community that lives with severe food allergies and are seeking a needle-free alternative to autoinjectors.
When it comes to treating anaphylaxis, time is of the essence. Delayed epinephrine administration or suboptimal exposure during anaphylactic events may increase the risk of hospitalizations and potentially fatal outcomes. There should be no hesitation in terms of treatment with rapid uptake.
Click here to view the poster presented at the meeting in more detail:
