FDA approves new Parkinson’s treatment following clinical trial led by USF Health researcher

The U.S. Food and Drug Administration (FDA) approved on Aug. 7 a new medication that lasts longer and requires fewer doses for treating Parkinson's Disease, potentially offering patients significant relief from the disease's debilitating symptoms.

The FDA's approval is based in part on findings of a study led by Robert A. Hauser, MD, MBA, professor in the Department of Neurology and director of the USF Health Parkinson's Disease and Movement Disorders Center at the USF Health Morsani College of Medicine.

Dr. Hauser was principal investigator for the multisite randomized, double-blind clinical trial that included 105 academic and clinical centers in the United States and Europe. He and colleagues published the findings last summer in JAMA Neurology. At the core of the findings is a novel method of boosting decreased dopamine levels with an extended-release formulation of an existing medication - carbidopa-levodopa - that can provide patients with longer "on" time between doses, so they are less likely to experience the return of slowness, stiffness and tremors, among other symptoms.

The new formulation is an oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets.

For more details on the study, please visit the USF Health News page here.

And for more details on the FDA approval, please visit here.