Bryn Pharma UTULY™ Phase 3 Data accepted as Late-Breaker at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting
New Data Also Accepted for Presentation at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting
RALEIGH, N.C.--(BUSINESS WIRE)--#allergyresearch--Bryn Pharma LLC, a privately held pharmaceutical company dedicated to finding a better way for patients and caregivers to treat anaphylaxis, today announced that results from its recently completed UTULY™ (intranasal epinephrine spray) Phase 3 pivotal clinical trial have been accepted and will be presented as late breaking news at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting in San Antonio, Tex., February 24-27, 2023. The poster, “13.2mg Intranasal Epinephrine Spray Demonstrates Comparable PK/PD and Safety to 0.3mg Epinephrine Autoinjector,” will be presented on Friday, February 24 at 3:15pm CT.
The primary objective of the pivotal trial was to evaluate whether the administration of the nasal spray could achieve a successful release profile with both short- and long-term pharmacokinetic (PK) and pharmacodynamic (PD) outcomes comparable to those seen with administration of the 0.3mg epinephrine autoinjector (EpiPen, generic).
New research has also been accepted at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) annual meeting in Atlanta, Ga., March 22-24, 2023. The poster, “The Effect of Nasal Congestion on the Bioavailability of Intranasally Administered Epinephrine in Healthy Adult Subjects with Seasonal Allergies,” will be presented on Friday, March 24 at 7:00am ET.
“We are excited to share new data that demonstrate UTULY has the potential to be a safe and effective solution, comparable to the EpiPen, yet with an easy to use, needle-free and small portable design for the emergency treatment of severe food allergy reactions, including anaphylaxis,” said David Dworaczyk, Ph.D., CEO of Bryn Pharma. “Anaphylaxis events are serious and at times life-threatening. We understand the importance of treatment without hesitation and the need for treatment options that reach maximum concentration quickly. We are dedicated to a strong scientific foundation for our innovative investigational approach with UTULY, and look forward to presenting these data in the coming months.”
About Bryn Pharma
Bryn Pharma, established in 2017, is a privately held pharmaceutical company founded by patients for patients. Bryn is focused on positively disrupting the existing market for epinephrine autoinjectors by delivering an accessible, easy-to-use alternative that better meets the needs of patients. Bryn Pharma seeks to provide this growing population at risk for anaphylaxis with A Better Way to be prepared for a life-threatening allergic reaction. For more information visit www.brynpharma.com.
Rebecca Novak Tibbitt