Bryn Pharma has presented data from a bioavailability study of its Utuly epinephrine nasal spray demonstrating that 13.2 mg dose of Utuly absorbed as fast and produced higher and longer-lasting epinephrine plasma levels than a 0.3 mg autoinjector. Compared to a 0.5 mg dose of epinephrine delivered via manual syringe, Utuly absorbed faster and reached comparable or higher exposure, the company said. The data were presented in a poster at the 2023 American Academy of Allergy, Asthma and Immunology annual meeting. Bryn announced in September 2022 that it had completed the pivotal study but did not present data at that time.
According to Bryn, the study found comparable safety data Utuly, the autoinjector, and the manual syringe, and Utuly was well tolerated with no safety issues unique to the intranasal formulation. No serious adverse events were reported.
Bryn CEO David Dworaczyk said, “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.”
Read the Bryn Pharma press release.
Read the Bryn Pharma poster from the AAAAI meeting.
