Bryn Pharma announced that it has initiated a PK/PD trial of its epinephrine spray in an updated delivery device, with topline data expected in the third quarter of this year. The company said that the trial will evaluate a two-spray, two-dose device in addition to a two-spray, single-dose device. According to the company, the new version of the delivery device includes a dose indicator, a more comfortable nozzle, extended finger flanges, and “enhanced reliability for emergency-use applications.”
In February 2023, Bryn announced that a bioavailability study of the epinephrine nasal spray, which it was then calling “Utuly,” demonstrated advantages compared to autoinjector. Bryn is pursuing the 505(b)(2) pathway for the nasal spray, which has Fast Track designation from the FDA.
Bryn Pharma CEO Joshua Ziel commented, “Initiation of this trial marks a milestone for Bryn as we advance our epinephrine nasal spray program with significant enhancements to our nasal spray device, including further reliability enhancements, easier handling, improved comfort and fit, as well as an integrated dose indicator for clear user feedback. This trial also provides the exciting opportunity to evaluate our innovative dual-dose profile, which has the potential to revolutionize anaphylaxis care by delivering two complete therapeutic doses in a single, lip-balm sized nasal spray.”
Read the Bryn Pharma press release
