AN ACUTE AND LONG-TERM STUDY WITH A DISPERSIBLE FORMULATION OF LEVODOPA BENSERAZIDE (MADOPAR(R)) IN PARKINSONS-DISEASE/

The clinical efficacy, tolerability and administration regimens of a d ispersible formulation of levodopa/benserazide (DM) were investigated in 30 patients with idiopathic Parkinson's disease, complicated by mot or fluctuations, All 30 patients showed delayed-''on'' phenomenon afte r administration of the first morning dose of standard levodopa (SM), and 20 showed delayed-''on'' phenomenon after the first afternoon dose , Patients were receiving standard formulations of levodopa as monothe rapy or in combination, A double-dose study of the dispersible vs the standard formulation was performed in 30 patients, 24 of whom particip ated in a 36-month, follow-up clinical study. In the long-term study, SM was replaced with DM by substituting the first morning dose or the first morning and first afternoon doses, In the double-dose study, mea n latency to ''on'' after the first morning dose was significantly sho rter with DM than with SM (p < 0.001), whereas the duration of ''on'' was similar with the two preparations, The post-prandial delayed-''on' ' in the 14 patients who responded to therapy was significantly shorte r for DM than for SM (p < 0.001). In the long-term study, the mean lat ency to ''on'' in all patients was significantly shorter than at basel ine (p < 0.001), Time spent in ''on'' during the active day increased significantly, and remained stable during the 36-month study. No chang es were apparent in the mean dosage of levodopa/day or the number of d oses/day, and no acute or long-term adverse events were reported. In c onclusion, these results confirm the long-term safety of the dispersib le formulation, and its improved efficacy compared with standard levod opa formulations, as monotherapy and in association with slow-release formulations.