In data presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Meeting in San Antonio, TX, an investigational 13.2mg intranasal (IN) epinephrine spray (UTULY) for anaphylaxis showed strong phase 3 trial results.¹

The late-breaking data indicated that the investigational IN epinephrine spray showed a stronger pharmacokinetic (PK) profile than that of the current standard of care, a 0.3mg IM autoinjector, which also has a similar safety profile.

The current standard reference product is the 0.3mg IM autoinjector, the outpatient standard of care, and it accounts for over 95% of prescriptions, according to the research.

“The rapid attainment and sustained level of therapeutic levels of epinephrine are critical to optimize the successful treatment of anaphylaxis,” stated David Dworaczyk, PhD, CEO of Bryn Pharma. “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.”

The intranasal epinephrine spray was rapidly-absorbed, at a comparable rate to the 0.3 mg auto injector. The epinephrine spray showed not only higher but also a greater sustenance of therapeutic epinephrine plasma levels versus the auto injector.

The phase 3 data also indicated that the new epinephrine spray had a quicker absorption rate than the inpatient standard of care, which is 0.5 mg IM in a manual syringe.

“When it comes to treating anaphylaxis, time is of the essence,” Dworaczyk noted. “Delayed epinephrine administration or suboptimal exposure during anaphylactic events may increase the risk of hospitalizations and potentially fatal outcomes. There should be no hesitation in terms of treatment with rapid uptake.”

The new data also indicated that the epinephrine spray had no serious adverse events (AEs) or deaths, and that its safety profile was comparable to the other 2 methods.

The phase 3 trial was conducted to assess prior results by comparing the PK data of a single 13.2 mg dose of the new epinephrine spray to the IM-administered epinephrine auto injector (0.3 mg) as well as the prefilled manual syringe (0.5 mg).

Dworaczyk compared the new product’s PK profile to that of the EpiPen in a recent HCPLive interview, adding that the plasma concentrations from the spray reach threshold levels of 100.2 grams per milliliter, as quickly as the EpiPen.

References

1. Dworaczyk, David & Hunt, Allen. (2023). 13.2mg Intranasal Epinephrine Spray Demonstrates Comparable PK/PD and Safety to 0.3mg Epinephrine Autoinjector. Journal of Allergy and Clinical Immunology. 151. AB317. 10.1016/j.jaci.2022.12.728.