Phase III Riluzole Data Presented At AAN

As forecast, results of the largest trial of a new treatment for amyotrophic lateral sclerosis or motor neurone disease have been presented at the 47th annual meeting of the American Academy of Neurology in Seattle, USA (Marketletter April 10). The 950-patient study has revealed that Rhone-Poulenc Rorer's Rilutek (riluzole), an NMDA antagonist, is the first drug treatment to prolong the survival of ALS patients.

Placebo or riluzole at one of three doses (50mg, 100mg or 200mg/day in three doses) was given to the ALS patients over a 14- to 18-month period. The primary statistical test of riluzole's efficacy (on survival) was an 18-month intent-to-treat analysis. The evaluation revealed a 12.7% increase in the number of patients alive after 18 months who received 100mg/day riluzole compared to placebo. 134 of the 236 patients (56.8%) on 100mg riluzole were alive after this period compared to 122 of 242 patients (50.4%) on placebo.

No additional benefit was observed in treating patients at the 200mg/day level, so all patients who completed the trial have been offered the option of continuing in an open-label study and receive a dose of 100mg/day riluzole. Significantly, the prolonged survival was seen in both limb-onset or bulbar-onset (facial) ALS sufferers - previously, Phase II data on the drug had suggested it would have an affect only on the bulbar-onset form.