Carbidopa/Levodopa ER Capsules (Rytary(®), Numient™): A Review in Parkinson's Disease.

Abstract

A new extended-release (ER) capsule formulation of carbidopa/levodopa (Rytary(®), Numient™, IPX066) is available for the treatment of Parkinson's disease (PD). Carbidopa/levodopa ER capsules contain beads of carbidopa and levodopa, designed to release the drugs at different rates in the gastrointestinal tract and provide constant therapeutic levodopa concentrations that are maintained for 4-5 h (after an initial peak at ≈ 1 h). In randomized phase III trials, oral carbidopa/levodopa ER was significantly more effective than placebo with regard to improving motor symptoms and activities of daily living in patients with early PD after 30 weeks' treatment, and provided significantly greater reductions in daily 'off-time' in patients with advanced PD than immediate-release (IR) carbidopa/levodopa or carbidopa/levodopa IR plus entacapone after a treatment period of 13 and 2 weeks, respectively, without increasing troublesome dyskinesia. The efficacy of carbidopa/levodopa ER was maintained during a 9-month open-label extension in patients with early or advanced PD. Carbidopa/levodopa ER was generally well tolerated in clinical trials, with the most common adverse events in the extension study being nausea and insomnia in patients with early PD and falls and dyskinesia in patients with advanced PD. Thus, carbidopa/levodopa ER is an effective and generally well-tolerated treatment option for the motor symptoms of PD, reducing periods of 'off-time' compared with carbidopa/levodopa IR without increasing troublesome dyskinesia.