Dr. David Dworaczyk explains phase 3 data showing a single intranasal dose of epinephrine produced a higher and more prolonged plasma curve compared to an intramuscular 0.3 mg autoinjector.
The plasma curve observed in the healthy adults following self-administration of a single intranasal dose of epinephrine, 13.2 mg, which consisted of 2 consecutive 6.6 mg sprays, was higher and more prolonged compared with an an intramuscular 0.3 mg autoinjector, according to the data.
When compared with 0.5 mg manual syringe, the intranasal route exhibited an AUC roughly equal to, or slightly better than 0.5 mg manual syringe, with a much faster uptake.
David Dworaczyk, PhD, CEO, Bryn Pharma, joined HCPLive for an interview to discuss his presentation of these phase 3 data at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Meeting in San Antonio, TX.
The study, "13.2mg Intranasal Epinephrine Spray Demonstrates Comparable PK/PD and Safety to 0.3mg Epinephrine Autoinjector" evaluated a spectrum of pharmacokinetic (PK) parameters including serial blood levels through 6 hours post-dose.
Additionally, investigators collected telemetry recordings, consistent telemetry recordings, as well as blood pressure, heart rate, and ECGs correlating with the plasma concentration blood draws.
"We did PK parameters, everything from a UC10 through a UC360, and all of the different parameters Cmax, Tmax on top of that as well, comparing the 3 different dosage forms: the nasal, the autoinjector, and the 0.5 manual syringe," Dworaczyk explained. "When you looked at all of those data, what we found was a different kind of perspective."
Bryn Pharma is in conversation with the US Food and Drug Administration (FDA) in order to prepare a New Drug Application (NDA).
"(The FDA) has seen our data and they agreed that we did deliver a PK profile that was higher and more prolonged compared to the EpiPen," he said. "We are in the final stages of what we need to do to file the NDA."