Bryn Pharma, which recently announced that it would use Aptar’s Bidose nasal device for delivery of its BRYN-NDS1C intranasal epinephrine, said that it has raised $17.5 million that it will use to prepare for US regulatory approval and commercialization of the nasal spray. BRYN-NDS1C has received Fast Track designation from the FDA, and the company plans to pursue the 505(b)(2) pathway.
According to the company, BRYN-NDS1C “complies with practice parameters by containing two doses of epinephrine in one portable device, replacing the need to carry two emergency auto-injectors.” A pivotal study of the product has recently completed dosing.
Bryn Pharma CEO David Dworaczyk said, “We formed the company with the singular goal of bringing an easy-to-use, needle-free, and convenient-to-carry solution to patients and their loved ones at risk of anaphylaxis. This financing follows our rapid advancement of the development and clinical testing of BRYN-NDS1C. The additional capital will be used to prepare for the rapid commercialization of the product once approved by the FDA.”
Read the Bryn Pharma press release.
