EASE LID clinical trial of ADS 5102 (amantadine) in Parkinsons published in JAMA Neurology- Adamas Pharmaceuticals

Adamas Pharmaceuticals announced that results of its Phase III EASE LID clinical trial of ADS 5102 (amantadine) extended-release capsules in Parkinson Disease were published online in JAMA Neurology. The randomized, double-blind, placebo-controlled EASE LID study met its pre-specified primary endpoint demonstrating that patients who received ADS 5102 experienced a significantly greater decrease in LID at 12 weeks than those who received placebo (p=0.0009), as measured by the Unified Dyskinesia Rating Scale (UDysRS).

This improvement was maintained at 24 weeks, with ADS 5102-treated patients again showing a significantly greater decrease than placebo-treated patients (p=0.0008). Additionally, the ADS 5102 group experienced significant improvements in key pre-specified, hierarchical secondary endpoints compared with the placebo group, as measured using the Parkinson�s disease home diary. 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. Adverse events (AEs) were reported for 89 percent of ADS 5102 patients and 60 percent of placebo patients, and most reported were mild to moderate.

A New Drug Application supporting ADS 5102 for the treatment of levodopa-induced dyskinesia (LID) in people with Parkinson's disease is under review by the FDA with 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.

See: "ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson Disease (EASE LID Study)A Randomized Clinical Trial" Rajesh Pahwa et al. JAMA Neurol. Published online June 12, 2017. doi:10.1001/jamaneurol.2017.0943