ADS-5102 is initially being developed by Adamas for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. ADS-5102, an investigational agent, is a long-acting, extended-release capsule formulation of amantadine HCl administered once daily at bedtime.
The randomized double-blind, placebo-controlled, parallel group study evaluated 83 patients with troublesome LID.
Patients were assigned to receive placebo or one of three dose levels of ADS-5102. Results from the study demonstrate that ADS-5102 significantly reduced dyskinesia, as measured by change in the Unified Dyskinesia Rating Scale (UDysRS) total score over eight weeks versus placebo at the 340 mg (p=0.005) dose level.
In addition, ADS-5102 significantly increased ON time without troublesome dyskinesia by 3 hours per day, as assessed by Parkinson’s disease patient diaries change from baseline relative to placebo at the 340 mg (p=0.008) dose level.
ADS-5102 was generally well tolerated; the most common adverse events were constipation, hallucinations, dizziness, and dry mouth.
"The Phase 2/3 EASED study suggests that ADS-5102 administered at bedtime improved dyskinesia in Parkinson’s disease patients," said principal investigator Rajesh Pahwa, MD, University of Kansas Medical Center, Kansas City, and lead author on the study.
"Over 40 percent of patients receiving levodopa to control their Parkinson’s disease symptoms develop motor fluctuations and dyskinesia within five years of treatment that can negatively impact their quality of life. There is a clear need for a medical treatment for dyskinesia that can be debilitating in some patients, and ADS-5102 is a promising therapy."