David Dworaczyk, PhD, Presents Phase 3 Data on Novel Intranasal Epinephrine

For more than 4 decades, self-injected epinephrine has been used as immediate treatment for anaphylaxis. Today, a novel intranasal (IN) epinephrine spray Utuly was introduced during a presentation on breakthrough phase 3 data at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Meeting in San Antonio, TX.

"Results from the study clearly showed that we had a product that delivers a pharmacokinetics profile that is higher and more prolonged compared to the EpiPen, with an equal or better rate of absorption so that the plasma concentrations reach threshold levels of 100.2 grams per milliliter, as rapidly as they do with an EpiPen," David David Dworaczyk, PhD, CEO, Bryn Pharma, said in an interview with HCPLive.

The study aimed to compare the pharmacokinetics (PK) of the novel intranasal epinephrine spray with an epinephrine autoinjector and prefilled manual syringe, which is the current standard for treatment. Utuly demonstrated an enhanced pharmacokinetics profile compared with the 0.3mg epinephrine autoinjector.

"(The plasma concentrations of Utuly) go up higher, and they stay high longer than an EpiPen–essentially twice as long as an EpiPen," he continued. "So, you have essentially twice as long between the initial event treatment and to seeking emergency medical attention."

Additionally, safety results for the route of administration for Utuly and intramuscular (IM) administration were comparable, indicating that Utuly was well-tolerated with no new safety signals for the intranasal route of administration. There were no significant adverse events reported in the study.