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Adamas Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. The ADS-5102 application has been given a Prescription Drug User Fee Act (PDUFA) target action date of August 24, 2017.
"This is an important milestone for patients, physicians and Adamas, as we are one step closer to approval of ADS-5102 for Parkinson's disease patients with levodopa-induced dyskinesia, which is an existing gap in their treatment journey," said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. "Over time, 90% of patients on levodopa therapy suffer from levodopa-induced dyskinesia. Currently, there is no FDA approved medicine for levodopa-induced dyskinesia for patients with Parkinson's disease. If approved, ADS-5102 will be the first and only medicine for Parkinson's disease patients with levodopa-induced dyskinesia."
The NDA for ADS-5102 was submitted in October 2016 and is supported by efficacy and safety data compiled from Adamas' full clinical program, which was designed to evaluate ADS-5102 for the treatment of LID in patients with Parkinson's disease. The comprehensive program included three placebo-controlled trials: EASED and two Phase 3 trials, EASE LID and EASE LID 3.
The controlled Phase 3 data for ADS-5102 presented in the NDA demonstrate a primary reduction of LID and a secondary reduction in OFF time in Parkinson's disease patients, with a manageable safety and tolerability profile. The NDA is also supported by data from an open-label safety study known as EASE LID 2, which enrolled patients from EASED, EASE LID and EASE LID 3, as well as LID patients who have undergone deep brain stimulation. The EASE LID 2 trial is ongoing, and patients are being followed for up to two years.
ADS-5102 is a chrono-synchronous amantadine therapy for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. ADS-5102 is dosed once daily at bedtime to time the delivery of drug levels of amantadine to waking hours when LID episodes are most frequent and movement control is needed most. An NDA for ADS-5102 is currently under review by the FDA for the treatment of LID in patients with Parkinson's disease. In April 2015, the FDA granted orphan drug status to ADS-5102 for this indication. Adamas is also investigating ADS-5102 for other indications earlier in the Parkinson's treatment journey, as well as in walking impairment in multiple sclerosis. ADS-5102 may have broad utility in hyper- and hypokinetic disorders.
