Bryn Pharma said that it has completed a pivotal study of its Utuly (BRYN-NDS1C) epinephrine nasal spray comparing PK/PD profiles of Utuly to a 0.3 mg dose of epinephrine delivered by autoinjector. According to the company’s web site, Bryn is pursuing the 505(b)(2) NDA pathway with Mylan’s EpiPen as the reference listed drug. In 2020, Bryn announced that it had raised $11 million for further development of the nasal spray, which is delivered via Aptar Pharma’s Bidose nasal device.
The company did not announce results from the pivotal trial, saying that it would present data at upcoming medical conferences; however, Bryn Pharma CEO David Dworaczyk said, “We are extremely encouraged with the results from our pivotal study comparing the needle-free Utuly nasal spray to the 0.3 mg IM autoinjector. 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.”
Bryn also said that it has completed a congestion study and a human factors program for Utuly but did not provide any details.
Read the Bryn Pharma press release.
