Last week, the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for a dyskinesia therapy. Dyskinesia -- characterized by uncontrolled, involuntary movements -- can be a side effect of the prolonged use of levodopa, the gold standard treatment for Parkinson's motor symptoms. The results of the FDA review will be announced by August, and if the medication is approved, it would be the first and only available therapy specifically designed to target levodopa-induced dyskinesia.
Developed by Adamas Pharmaceuticals, the drug is an extended-release formulation of amantadine (ADS-5102) that is taken once daily at bedtime. Compared with a shorter-acting form of amantadine already on the market, this new therapy is intended to control symptoms when they are most prevalent (during the day), while not interfering with sleep.
The NDA submitted in October includes a report on safety and efficacy outcomes from three placebo-controlled trials. These trials measured patient response to the drug using the Unified Dyskinesia Rating Scale, a tool supported by The Michael J. Fox Foundation.