Bryn advances anaphylaxis nasal spray after completing pivotal trial

Bryn Pharma is advancing its nasal spray challenger to EpiPen autoinjectors. Having wrapped up a pivotal study that pitted the two rivals against each other, the North Carolina-based drug developer is moving forward through the regulatory process. 

Epinephrine autoinjectors are widely prescribed to treat anaphylaxis in outpatient settings. However, the limitations of the treatments, such as cost, convenience and fear of needles, deter some patients from carrying two devices with them, as recommended, and thereby increase the risk they will suffer severe complications if they have an allergic reaction.

Bryn is part of a group of drug developers working to deliver better options, in its case the Utuly nasal spray. The candidate, previously known as BRYN-NDS1C, is designed to enable patients to self-treat anaphylaxis by spraying epinephrine up their nostrils. 

Last week, Bryn disclosed the completion of a pivotal study that compared Utuly to 0.3-mg intramuscular doses of epinephrine delivered using an autoinjector. The company is yet to disclose the results of the trial, which looked at short- and long-term pharmacokinetic and pharmacodynamic outcomes, but Bryn CEO David Dworaczyk, Ph.D., said the team is “extremely encouraged” by the data.

“Our findings have given us the confidence to move forward in the regulatory process. We are thrilled to be one step closer to improving the lives of people who live in fear of life-threatening allergic reactions and who are looking for alternatives to costly and cumbersome autoinjectors,” Dworaczyk said in a statement.

The update from Bryn, which teamed up with Aptar Pharma to use its Bidose device, is the latest in a series of releases by companies trying to muscle in on the anaphylaxis market by improving the delivery of epinephrine. In recent months, Aquestive Therapeutics has shared data on its oral epinephrine film, Windgap Medical has raised cash to develop smaller autoinjectors and ARS Pharmaceuticals has inked a reverse merger to fund commercialization of its nasal spray.