The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ADS-5102 (amantadine extended-release capsules; Adamas) for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease.
The NDA submission was based on data from 3 placebo-controlled trials, EASED, EASE LID and EASE LID 3, which evaluated the safety and efficacy of ADS-5102 in Parkinson’s disease patients with LID. Results showed that patients treated with ADS-5102 demonstrated a primary reduction of LID and a secondary reduction in OFF time, as well as a manageable and tolerable safety profile. In addition, data from an ongoing safety trial, EASE LID 2, also supported the NDA.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 24, 2017, to make a decision on the NDA. If approved, ADS-5102 will become the first and only drug therapy for Parkinson’s disease patients with LID.
ADS-5102 is a chrono-synchronous amantadine therapy administered once daily at bedtime to time the delivery of amantadine drug levels to waking hours when LID episodes are most frequent.
Adamas Announces U.S. FDA Acceptance of ADS-5102 New Drug Application for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson’s Disease [news release]. Emeryville, CA: Adamas Pharmaceuticals newsroom. January 6, 2017; http://ir.adamaspharma.com/releasedetail.cfm?ReleaseID=1006890
This article originally appeared on MPR