Abstract

<h3>Introduction</h3> The intranasal (IN) epinephrine spray (ARS-1) is an investigational, needleless alternative to epinephrine injection for patients with severe systemic allergic reactions. <h3>Methods</h3> This single-dose, partially randomized crossover phase 1 study investigated the pharmacokinetics (PK) and pharmacodynamics (PD) of ARS-1 2 mg IN (under normal conditions and with induced rhinitis) and manual intramuscular (IM) injection (0.3 mg and 0.5 mg) in subjects with seasonal allergies. IRB approval was obtained for this study. <h3>Results</h3> Thirty-six subjects were included in the study. Mean C<sub>max</sub> values (pg/mL) with ARS-1 (491) and ARS-1 with rhinitis (309) were higher than or similar to those for 0.3 mg (283) or 0.5 mg (452) IM injection. Median t<sub>max</sub> values (minutes) were lowest with ARS-1 (20.0) and ARS-1 with rhinitis (6.00) compared with either IM dose (both 45.00). Mean E<sub>max</sub> for systolic blood pressure (SBP; mmHg), diastolic blood pressure (DBP; mmHg), and heart rate (HR; bpm) with ARS-1 (20.8, 10.0, 18.5 respectively) and ARS-1 with rhinitis (15.0, 7.15, and 10.8) was higher than or comparable to that of 0.3 mg IM (13.4, 5.26, and 11.1) and 0.5 mg IM (15.2, 5.69, 13.6). Similarly, the mean AUEC<sub>last</sub> in SBP, DBP, and HR for both ARS-1 groups was higher than or similar to either IM group. <h3>Conclusion</h3> PK and PD parameters with ARS-1 2 mg with and without allergic rhinitis were higher/better or comparable with those of 0.3 or 0.5 mg IM injection.

Full Text
Paper version not known

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.