FDA Approves Designation of IV Baclofen as Orphan Product

Minneapolis, Minn.
Jul. 1, 2020

IV Baclofen, a muscle relaxant drug, benefits individuals who experience dystonia (abnormal muscle tension) or spasticity (muscle stiffness or rigidity) caused by cerebral palsy, multiple sclerosis, brain or spinal cord injury. The drug is currently available as oral tablets and as an intrathecal solution delivered through a pump into the spinal column. However, if illness or mechanical problems with the intrathecal pump occur, or if a patient cannot take the drug by mouth, baclofen administration can be interrupted, causing withdrawal symptoms. The intravenous formulation of the drug will allow more effective management and prevention of complications associated with abrupt drug withdrawal.

The orphan product designation application was submitted by Allaysis, the company developing IV baclofen with whom the University has a license agreement. It was submitted in close collaboration with faculty in the college's Center for Orphan Drug Research including Linda Krach, MD; Bob Kriel, MD; Lisa Coles, PhD; and James Cloyd, PharmD. The drug formulation previously passed a Phase I study designed by Lisa Coles and recent graduate student, Natalie Schmitz, PharmD, MPS, PhD.

The next step in the development of the product is for Allaysis to submit a new drug application to the FDA in the next month with an anticipated Agenct approval sometime in the scond half of 2021.


College of Pharmacy, pharm@umn.edu

The University of Minnesota College of Pharmacy, the only school of pharmacy in Minnesota, offers its program on the Twin Cities and Duluth campuses. Founded in 1892, the College of Pharmacy educates pharmacists and scientists, and engages in research and practice to improve the health of the people of Minnesota and society. The college is part of the health sciences, which are home to the University of Minnesota’s six health professional schools and colleges as well as several health-related centers and institutes.