Ropinirole 24Hour Prolonged Release

Ropinirole 24-hour prolonged release (GlaxoSmithKline) has completed Phase II/III trials for PD. The dopamine agonist component is identical to the currently available drug, ropinirole. The prolonged release tablet employs a Geomatrix® technology involving altering layers of active drug and erodible hydroxypropyl methylcellulose polymers, which slow absorption of the drug potentially leading to a smoother phar-macokinetic profile, improved tolerability and efficacy, and reduced motor fluctuations. This formulation is already used in medications marketed within the United States including Paxil CR®. The ropinirole Geomatrix system differs slightly from previous systems in that it employs a carboxymethylcellulose sodium. Pharmacoki-netic studies show that this safely slows absorption without any dose dumping. A 393-patient multicenter, Phase III trial recently compared the 24-hour prolonged release ropinirole preparation and placebo (6). The initial dose was 2 mg/day which was titrated over four weeks to 8 mg/day and if needed to a maximum dose of 24 mg/day over a period of 8 weeks. Overall, off time was reduced by 2.1hr/day compared to 0.3hr/day with placebo (P < 0.0001). No unexpected adverse events were reported, and compared with studies evaluating immediate release ropinirole, adverse events appeared to be reduced.

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