Data presented at the American Society for Clinical Pharmacology and Therapeutics annual meeting show promise for Utuly, a novel intranasal epinephrine spray for treating anaphylaxis.
Promising data presented at the American Society for Clinical Pharmacology and Therapeutics annual meeting continue to support Utuly, a novel intranasal epinephrine spray for treating anaphylaxis.
In an interview with HCPLive, David David Dworaczyk, PhD, CEO, Bryn Pharma, said Utuly exhibited a higher and more prolonged pharmacokinetic (PK) profile, and has now demonstrated similar heart rate and blood pressure effects when compared with an epinephrine autoinjector.
"We're clearly showing that there is a positive outcome from the heart rate and blood pressure changes that are the same as with the EpiPen, but in addition to that, we do show that the epinephrine blood levels, in fact, do go higher and are sustained longer than with the epi-pen," he stated.
The clinical studies followed methodologies recommended by the US Food and Drug Administration (FDA). Bryn Pharma has been in communication with the agency about the development of Utuly since the preclinical data were presented and positively received by the FDA.
Data featured at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Meeting confirmed the go-to-market dose of Utuly.1
"We do have a confirmed dose that is as good as, or better than, the EpiPen with a very rapid absorption and a PK profile that would suggest a prolonged exposure to therapeutic levels of epinephrine," he said.
The latest data reflect the congestion study, which compared the results of administering the nasal spray in the same nostril and in each nostril with the impact of a congested model and a non-congested model, as well as with the use of an EpiPen.
According to the results, the nasal spray was absorbed 60-70% more with nasal congestion, and even with high epinephrine doses, there were no unexpected adverse events.
Dworaczyk explained that the plasma concentrations of epinephrine were sustained for a longer period of time than with the EpiPen. Although no clinical efficacy studies have been conducted in anaphylaxis, he believes that prolonged exposure to therapeutic levels of epinephrine will result in a significant therapeutic effect.
"It's a very exciting time for the work that we've done," he said.