Phase 3 Results Published for Investigational Levodopa-Induced Dyskinesia Treatment
Results from the Phase 3 EASE LID clinical trial, published online in JAMA Neurology, show that the investigational ADS-5102 (amantadine, Adamas Pharmaceuticals) reduces levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD).
In the randomized, double-blind, placebo-controlled study, patients who received ADS-5102 experienced a significantly greater decrease in LID at 12 weeks than those who received placebo, as measured by the Unified Dyskinesia Rating Scale (UDysRS). The authors noted that this improvement was maintained at 24 weeks, with ADS-5102-treated patients again showing a significantly greater decrease than placebo-treated patients. Additionally, ADS-5102 treatment resulted in a statistically significant increase in ON time without troublesome dyskinesia and a statistically significant decrease in OFF time at 12 and 24 weeks.
The most common adverse events for ADS-5102 versus placebo were visual hallucinations, peripheral edema, and dizziness, while no study drug-related serious AEs were reported. Also, 13 patients in the ADS-5102 group discontinued treatment.
Adamas has submitted a New Drug Application (NDA) supporting ADS-5102 extended release capsules. It has a Prescription Drug User Fee Act (PDUFA) action date of August 24, 2017. If approved, ADS-5102 will be the first and only medicine indicated for the treatment of LID in people with Parkinson's disease.