Breaking News: A New Dyskinesia Drug Will Be Submitted to FDA This Year

By Holly Teichholtz

A new formulation of amantadine to better treat levodopa-induced dyskinesia is entering the home stretch. Its developer, Emeryville, California-based biotech Adamas Pharmaceuticals, expects to file an NDA (New Drug Application) with the U.S. Food and Drug Administration later this year.

According to Nasdaq:

“Data from the study demonstrated a statistically significant reduction in LID at 12 weeks in patients receiving ADS-5102 compared with placebo, as assessed by the Unified Dyskinesia Rating Scale (UDysRS). The candidate was safe and generally well tolerated. The study met its primary endpoint.[…] Results from the study showed an improvement in activities of daily living (ADLs) in PD patients.”

As FoxFeed reported in December 2015, the company measured the impact of the drug using a new dyskinesia rating scale developed by Chris Goetz, MD, and Glenn Stebbins, PhD, of Rush University Medical Center with support from The Michael J. Fox Foundation.

Source:: Fox Feed Blog

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