MedicalResearch.com Interview with: [caption id="attachment_70637" align="alignleft" width="133"] Dr. Casale[/caption] Thomas B. Casale, M.D. Professor of Medicine and Pediatrics Chief of Clinical and Translational Research Division of Allergy and Immunology USF Health Morsani College of Medicine University of South Florida Tampa, Florida MedicalResearch.com: What is the background for this study? Response: The data leading to FDA approval of neffy came from extensive pharmacokinetic and pharmacodynamic studies. As with previous epinephrine delivery devices, the FDA asked for data showing that after delivery of neffy the epinephrine blood levels and expected changes in pulse and blood pressure were similar to those achieved with injectable formulations of epinephrine. neffy performed as expected with blood levels of epinephrine bracketed by those achieved with EpiPen and a needle and syringe along with increases in pulse and blood pressure compatible with the epinephrine levels measured. Additionally, clinicians are interested in whether neffy would perform similarly in real clinical situations. The data from the neffy experience program provides real-world assurance that neffy can effectively treat acute allergic reactions. Given the large number of patients and the similar findings to those achieved with injectable epinephrine in previous studies, the data should provide assurance that neffy can be an effective substitute for injectable epinephrine in patients that desire a needle-free option.