FDA Designates Intravenous Baclofen an Orphan Product
May. 11, 2020
The FDA recently approved designation of intravenous baclofen as an orphan product. The designation application was submitted by Allaysis, the company developing IV baclofen, in close collaboration with faculty in the Center for Orphan Drug Research including Linda Krach, MD, Bob Kriel, MD, Lisa Coles, PhD and Jim Cloyd, PharmD. Allaysis has a license agreement with the University.
Much of the development work has been completed including a Phase I study, which will be a primary component in the 505(b)2 NDA. That study that was designed by Lisa Coles and one of our recent graduate students, Natalie Schmitz.
With orphan designation in hand, the company plans to soon submit an NDA with an expected approval sometime in the 2nd half of 2021.