David Dworaczyk, PhD: FDA Review is Anticipated for an Epinephrine Nasal Spray
Bryn Pharma is planning to submit the New Drug Application for Utuly this year and expects to receive approval early next year.
The development of Utuly, a new nasal spray as an alternative to the traditional epinephrine autoinjector for people with severe allergies, is moving forward.
David Dworaczyk, PhD, chief executive officer of Bryn Pharma, explained that the company has a clear understanding of what is required for the New Drug Application (NDA) submission, and plans to submit the NDA this year and receive approval early next year.
While some additional data is needed to confirm previous results, Dworaczyk was confident that the clinical trial data demonstrated the efficacy and safety of the nasal spray.
The nasal spray is an exciting development for people with severe allergies who rely on epinephrine, he said. The alternative to the autoinjector has the potential to offer patients a more convenient option for emergency treatment.
"At the end of the day, we're about 2 inches from the goal line–we think we've done everything that we need to do to have a viable product that presents patients with a viable alternative to the autoinjector that works, as well as, or better than, what they're used to seeing," Dworaczyk explained.
