Bryn Pharma (formerly Epi-Now) announced that it has signed a deal with Aptar Pharma for worldwide exclusive rights to use Aptar’s Bidose nasal delivery device for its BRYN-NDS1C intranasal epinephrine for the treatment of anaphylaxis. The company said that it has recently completed dosing in a pivotal clinical trial using the device.
According to Bryn’s website, BRYN-NDS1C has received Fast Track designation, and the company plans to submit a 505(b)(2) NDA.
Bryn Pharma CEO David Dworaczyk said, “Studies have shown that the majority of people at risk for anaphylaxis do not carry two epinephrine auto-injectors with them at all times, putting them at greater risk of severe complications during an allergic reaction. We are excited to partner with Aptar Pharma to develop a product that can provide patients with a life-saving treatment that fits in a pocket, is easy to use and complies with practice parameters.”
Read the Bryn Pharma press release.