Effects on blood pressure, heart rate similar with epinephrine nasal spray, autoinjector
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Key takeaways:
- Researchers pooled results from four studies of epinephrine administered by nasal spray and by autoinjector.
- Blood pressure and heart rate were measured 15 times in the 6 hours after dosing.
WASHINGTON — Four pooled studies noted similar pharmacodynamic performance for epinephrine delivered via nasal spray or autoinjector, according to a poster presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.
These similarities persisted whether the spray was delivered in opposite nostrils or in the same nostril, Jay A. Lieberman, MD, FACAAI, associate professor, University of Tennessee Health Science Center, and colleagues wrote.
“No one wants to inject themselves if they can do a pill or a tablet or a nasal spray,” Lieberman, who also is a member of the Healio Allergy/Asthma Peer Perspective Board, told Healio.
This fear of needles is the primary reason why patients with allergy want an alternative to autoinjectors for epinephrine delivery, Lieberman explained. Autoinjectors also are large, so people do not like carrying them, he continued.
“Nasal spray devices would be smaller, maybe easier to carry, and more likely, hopefully, to be used,” Lieberman said.
In four open-label phase 1 crossover studies, the researchers compared pharmacodynamic profiles of healthy adults (53% men; mean age, 39 years) who received Bryn Pharma’s NDS1C epinephrine nasal spray (ENS) and epinephrine via autoinjector.
Treatment arms in these studies included single 13.2 mg doses of ENS delivered in two consecutive sprays of 6.6 mg each in opposite nostrils (n = 198) or in the same nostril (n = 74), as well as 0.3 mg doses delivered by autoinjector (n = 196).
Trained clinical personnel administered all treatments. The second 6.6 mg doses of the nasal spray were administered within 10 seconds of the first dose.
Subjects served as their own controls in all four studies. There was at least 1 day between the ENS and autoinjector doses for washout purposes and at least 14 days between both ENS treatment periods.
The researchers measured systolic and diastolic blood pressure as well as heart rate 30, 20 and 10 minutes before each dose and 1, 3, 5, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 360 minutes after each dose. Baselines for each participant were calculated by averaging three pre-dose measurements for blood pressure and heart rate.
The researchers called the effects of treatment on systolic and diastolic blood pressure in all three treatment groups similar in pattern and magnitude. The effects on heart rate in all three treatment groups also were similar in pattern and magnitude over all timepoints.
There were no significant differences in post-dose values for systolic and diastolic blood pressure or for heart rate between ENS and autoinjector treatment. All three treatment groups achieved plateaus in blood pressure and heart rate as well.
The researchers did not report any correlations between pharmacodynamic effects and plasma epinephrine concentrations, with a coefficient of determination of 0.032 or less for changes from baseline in systolic and diastolic blood pressure and heart rate compared with plasma concentrations over time.
Finally, Lieberman said, adverse events were mild with ENS.
“The pharmacodynamic data over time in healthy volunteers essentially mirrors or matches the autoinjector,” Lieberman said. “That’s promising.”
Reference:
- Bryn Pharma to present positive results from three new analyses further supporting use of its epinephrine nasal spray in adults at the 2024 AAAAI annual meeting. https://www.brynpharma.com/docs/Bryn-Pharma-to-Present-Clinical-Data-at-AAAAI-240222.pdf. Published Feb. 22, 2024. Accessed Feb. 24, 2024.
For more information:
Jay A. Lieberman, MD, FACAAI, can be reached at jlieber1@uthsc.edu.