ADS-5102 is a high-dose amantadine taken once-daily at bedtime. ADS-5102 was designed to control the initial rate of rise in plasma concentration to mitigate the risk of central nervous system adverse events observed shortly after administration. This dosing regimen results in sustained high plasma levels of amantadine during morning and throughout waking hours when dyskinesia occurs, thereby improving the benefit-risk profile of the drug. If approved, ADS-5102 will meet a significant unmet need, as the first and only medicine approved for dyskinesia in people with Parkinson’s disease.
The Phase 3 ADS-5102 levodopa-induced dyskinesia clinical program was conducted at movement disorder centers across the United States, Canada and Europe. The program included three placebo-controlled trials (Phase 2/3 EASED, Phase 3 EASE LID, and Phase 3 EASE LID 3), and an ongoing, long-term, open-label Phase 3 EASE LID 2 trial. The two placebo-controlled Phase 3 trials met their primary and all key secondary endpoints.
The New Drug Application supporting ADS-5102 for the treatment of levodopa-induced dyskinesia 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.