FDAnews Device Daily Bulletin

Adamas Present Results of Pivotal Trial of ADS-5102 for the Treatment of Levodopa-induced Dyskinesia in Parkinson’s Disease Patients

Sept. 22, 2016

The company revealed the results of the Ease LID 3 study, the second Phase III trial of ADS-5102 extended-release capsules for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD).

The trial met its primary endpoint which was the reduction of the UDysRS (Unified Dyskinesia Rating Scale) total score at week 12 (p<0.0001), reflecting a decrease in the duration, intensity and disability associated with LID.

Adamas will be submitting a new drug application for ADS-5102 to the FDA later this year. — Cynthia Jessup

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