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Adamas Pharmaceuticals Presents Positive Clinical Data For ADS-5102, A Treatment For Levodopa-Induced Dyskinesia, At The World Parkinson's Congress
Date:10/2/2013

roups: placebo, 260 mg ADS-5102, 340 mg ADS-5102 and 420 mg ADS-5102.  Both the 340 mg and 420 mg ADS-5102 dose levels significantly reduced LID as measured by the change in Unified Dyskinesia Rating Scale (UDysRS) total score over eight weeks versus placebo, meeting the primary endpoint for the clinical study.  Of note, the reduction in LID was seen at two weeks following the first dose of study medication.  At week 8, the ON time without troublesome dyskinesia as measured by patient diaries was 11.0 hours, 11.5 hours, and 12.1 hours for the 260 mg, 340 mg, and 420 mg dose levels, respectively, compared to 8.0 hours for placebo.  These findings were statistically significant, demonstrating an increase of about 3 hours over placebo compared to baseline values.  ADS-5102 also demonstrated statistically significant functional improvement in dyskinesia as assessed by the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV, a measure of the degree of impact that dyskinesia has on the patient's daily function in terms of activities and social interactions.

Treatment with ADS-5102 did not result in worsening of PD, as measured by the MDS-UPDRS combined score (Parts I, II and III).  The adverse events reported in this study were typically mild to moderate in severity and consistent with Parkinson's disease and the known amantadine safety profile.  There was no difference from placebo in the incidence of sleep-related adverse events.

Data from the Phase 2/3 study were presented today in a poster entitled "Safety and Efficacy of ADS-5102 in Levodopa-Induced Dyskinesia (EASED Study)" (Abstract #1311.00) at 11:30 am ET at the World Parkinson's Congress in Montreal, Canada.  The poster has also been selected for a "Guided Poster Tour" between 5:15-6:45 pm ET.  Additional details of the EASED study results may be found on the Adamas website.

About the EASED
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SOURCE Adamas Pharmaceuticals, Inc.
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