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Extended-Release Amantadine (Nurelin) Shows Promise in Parkinson’s Disease
Data from a phase II/III trial of ADS-5102 (Nurelin; Adams Pharmaceuticals), an investigational extended-release formulation of amantadine, has met the study’s primary endpoint. ADS-5102 is intended for once-nightly administration for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD).
Results from the study will be presented at the 17th International Congress of Parkinson’s Disease and Movement Disorders, to be held June 16–20 in Sydney, Australia.
The randomized, double-blind, placebo-controlled EASED (Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia) trial enrolled 83 subjects with PD. The study’s primary efficacy analysis compared ADS-5102 with placebo for the reduction of LID after 8 weeks of treatment, as assessed by the Unified Dyskinesia Rating Scale (UDysRS). Secondary efficacy outcome measures included changes in a standardized PD diary; overall PD clinical status, as assessed by the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS); and fatigue, as measured using the Fatigue Severity Scale. The trial also included an assessment of dose response for ADS-5102.
The study enrolled male and female subjects aged 30 to 85 years who had PD and were experiencing troublesome LID. The study participants were randomly assigned to receive a low, medium, or high dose of ADS-5102 or placebo once-nightly for 8 weeks with a 2-week safety follow-up.
ADS-5102 is an investigational, extended-release formulation of amantadine in development for the treatment of central nervous system (CNS) disorders, including LID in PD. Designed for once-nightly administration, the “chronotherapeutic” profile of ADS-5102 is characterized by a slow increase in amantadine plasma concentrations, which is expected to result in high plasma concentrations during the daytime hours, when LID can be troublesome, and low plasma concentrations overnight. According to the drug’s developer, the low overnight amantadine plasma concentrations may reduce the insomnia, sleep disturbances, and vivid dreams occasionally associated with amantadine.
Source: Adams Pharmaceuticals; June 10, 2013.