Over the past year or so, we've told you about a dyskinesia drug that is advancing toward U.S. Food and Drug Administration (FDA) approval. This week, Adamas Pharmaceuticals announced new data for this therapy, an extended-release formulation of amantadine designed to be taken once daily at bedtime. Results from two clinical trials demonstrated that individuals with Parkinson's disease (PD) treated with the drug experienced not only a reduction in levodopa-induced dyskinesia (involuntary, uncontrolled movements that can develop with long-term levodopa use and prolonged duration of PD) but also "off" time (periods when PD symptoms return). There is currently no approved therapy to treat dyskinesia, although medication adjustments can help and immediate-release amantadine often is prescribed.
The new data includes pooled analyses from two Phase 3 clinical trials called EASE LID and EASE LID 3. Consistent with previous reported results, the company's compound (ADS-5102) was effective in reducing levodopa-induced dyskinesia (LID) and "off" time in those with PD. LID was measured using the Unified Dyskinesia Rating Scale, a tool that was developed and validated with support from The Michael J. Fox Foundation. "Off" time was measured using patient home diaries.
"We continue to be highly-encouraged by the strength and consistency of the ADS-5102 data, as we believe it demonstrates that ADS-5102, if approved, has the potential to be an important new treatment for people with Parkinson's disease," stated Gregory T. Went, PhD, chairman and chief executive officer of Adamas Pharmaceuticals, Inc. in a press release.
A few months ago, Adamas announced that the FDA accepted its new drug application for extended-release amantadine. A decision is expected in late August.