ADS-5102, a high-dose amantadine therapy, decreases the duration, intensity and debility of the muscle movements, clinical trials have shown.
The problems, which range from slight hand tremors to uncontrollable upper body movements, stem from the long-term use of an amino-acid based therapy for Parkinson’s. That amino acid is levodopa, and the involuntary muscle movements are known as levodopa-induced dyskinesia (LID).
Adamas’ presentations on ADS-5102, also known as amantadine hydrochloride, will be at the 69th annual meeting of the American Academy of Neurology April 22-28 in Boston, the company said in a news release.
The presentations will cover two of the three Phase 3 clinical trials of ADS-5102 extended-release capsules as a treatment for LID in Parkinson’s, EASE LID and EASE LID 3.
EASE LID was a placebo-controlled randomized Phase 3 clinical trial (NCT02136914) that examined the effectiveness and safety of a 340-mg dose of ADS-5102 that patients received once a day, at bedtime, for 24 weeks.
EASE LID 3 was a placebo-controlled, randomized Phase 3 clinical trial (NCT02274766) that also looked at the effectiveness and safety of ADS-5102 in treating LID in Parkinson’s. Patients received one dose a day at bedtime.
In September 2016, Adamas reported that, after 12 weeks, EASE LID 3 had met its primary goal of reducing Parkinson’s patients’ scores on the Unified Dyskinesia Rating Scale. The drop in the scores indicated that ADS-5102 had decreased the duration, intensity, and disability associated with LID, the company said.
ADS-5102 also reduced Parkinson’s patients’ off-time, the period when Parkinson’s symptoms returned because the effects of levodopa treatment had worn off.
Another study, called EASED, was a placebo-controlled, randomized Phase 2/3 clinical trial (NCT01397422) that looked at the effectiveness and tolerability of three dose levels of ADS-5102 once a day in 83 Parkinson’s patients with LID.
In January the U.S. Food and Drug Administration (FDA) agreed to review Adamas’ New Drug Application (NDA) for ADS-5102 as an LID treatment in Parkinson’s.