A new drug for levodopa-induced dyskinesia -- involuntary, uncontrolled movements that can develop with long-term use of levodopa combined with a prolonged course of Parkinson's disease (PD) -- is one step closer to potentially reaching market. Adamas Pharmaceuticals recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). A decision regarding approval is expected within 10 months.
The therapy, an extended release formulation of amantadine (ADS-5102), is designed to be taken once daily at bedtime. Medication levels are meant to peak during the day, when control of dyskinesia is needed most, and decrease at night, when medication side effects might otherwise interfere with sleep. If approved, this drug would be the first specifically indicated for levodopa-induced dyskinesia. (A shorter-acting form of amantadine often is currently used to treat dyskinesia but is not specifically approved for dyskinesia. It also can possibly cause insomnia, a side effect the new formulation attempts to avoid.)
The NDA includes drug safety and efficacy information from three placebo-controlled trials, which tested the drug in a total of 286 people with Parkinson's who have levodopa-induced dyskinesia. These trials measured dyskinesia using the Unified Dyskinesia Rating Scale -- a tool that MJFF funding helped to develop.
As drugs such as this one move through the pipeline and to market, treatment options expand, unmet needs are addressed and, hopefully, the daily lives of people with PD improve as well.