General Information

Rilutek (riluzole) is a member of the benzothiazole class.

Rilutek is specifically indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Rilutek is supplied as tablets for oral administration. The recommended dosage is 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal.

Mechanism of Action

Rilutek (riluzole) is a member of the benzothiazole class. The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown.

Side Effects

Adverse effects associated with the use of Rilutek may include, but are not limited to, the following:

• asthenia
• nausea
• dizziness
• decreased lung function
• abdominal pain

Clinical Trial Results

The efficacy of Rilutek was demonstrated in two studies (Study 1 and 2) that evaluated Rilutek 50 mg twice daily in patients with amyotrophic lateral sclerosis (ALS). Both studies included patients with either familial or sporadic ALS, a disease duration of less than 5 years, and a baseline forced vital capacity greater than or equal to 60% of normal.

Study 1 was a randomized, double-blind, placebo-controlled clinical study that enrolled 155 patients with ALS. Patients were randomized to receive Rilutek 50 mg twice daily (n=77) or placebo (n=78) and were followed for at least 13 months (up to a maximum duration of 18 months). The clinical outcome measure was time to tracheostomy or death.

The time to tracheostomy or death was longer for patients receiving Rilutek compared to placebo. There was an early increase in survival in patients receiving Rilutek compared to placebo. Among the patients in whom the endpoint of tracheostomy or death was reached during the study, the difference in median survival between the Rilutek 50 mg twice daily and placebo groups was approximately 90 days.

Study 2 was a randomized, double-blind, placebo-controlled clinical study that enrolled 959 patients with ALS. Patients were randomized to Rilutek 50 mg twice daily (n=236) or placebo (n=242) and were followed for at least 12 months (up to a maximum duration of 18 months). The clinical outcome measure was time to tracheostomy or death.

The time to tracheostomy or death was longer for patients receiving Rilutek compared to placebo. Among the patients in whom the endpoint of tracheostomy or death was reached during the study, the difference in median survival between Rilutek and placebo was approximately 60 days.

Although Rilutek improved survival in both studies, measures of muscle strength and neurological function did not show a benefit.