Adamas Pharmaceuticals Inc. reported positive data from the ongoing phase 3 trial of ADS-5102, or amantadine, extended-release capsules for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease.
Two subgroups of patients, who underwent prior deep brain stimulation treatment and those who switched from amantadine immediate-release to ADS-5102, showed a rapid and sustained reduction in dyskinesia, which is an impairment of voluntary movement, and OFF. OFF periods refer to the re-emergence of Parkinson's symptoms.
Overall, the drug was well tolerated and the treatment effect on motor complications, as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part IV score, was maintained for up to 88 weeks.
Among patients previously treated with amantadine immediate-release, switching to ADS-5102 provided a three-point, statistically significant reduction on the rating scale at eight weeks. The treatment effect experienced by patients previously treated with amantadine immediate-release was similar to that of previous placebo-treated patients, and was maintained for up to 64 weeks.
Patients who underwent prior deep brain stimulation treatment and were switched to ADS-5102 also had a comparable reduction on the rating scale.
All subgroups achieved reductions in motor complications without compromising the underlying control of Parkinson's symptoms, as assessed by Parts I to III of the rating scale.
A new drug application supporting ADS-5102 for the indication is under review by the U.S. Food and Drug Administration, with a target action date of Aug. 24.