In a single-center, open-label, single-dose, randomized, 5-period, crossover, comparative bioavailability study, healthy participants (n=32), under fasting conditions, were randomized to receive
In fact, 7 out of 10 patients newly diagnosed with ALS are prescribed riluzole each year.7,a
aAs based on IQVIA/NBRX data 01/20-12/20.
Two pivotal clinical trials found that riluzole, compared with placebo, increased the time to death or tracheostomy in patients with ALS.3
Original RILUTEK study design 13
Study 1 was a randomized, double-blind, placebo-controlled clinical study that enrolled 155 patients with either familial or sporadic ALS, a disease duration of less than 5 years, and a baseline forced vital capacity ≥ 60% of normal. Patients were randomized to receive riluzole 50 mg tablets 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.
Original RILUTEK study design 23
Study 2 was a randomized, double-blind, placebo-controlled clinical study that enrolled 959 patients with either familial or sporadic ALS, a disease duration of less than 5 years, and a baseline forced vital capacity ≥ 60% of normal. Patients were randomized to riluzole 50 mg tablets 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.
Adverse reactions in pooled placebo-controlled trials (studies 1 and 2) in patients with ALS1
(RILUTEK) 50 mg Twice daily
|Decreased lung function||10||9|
|Urinary tract infection||3||2|
Mitsubishi Tanabe Pharma America, Inc. is committed to advancing treatment options for people living with ALS.
Discover another treatment option to consider in your patients' ALS journeysLearn More
Important Safety Information
Warnings and Precautions
The use of
Interstitial Lung Disease
The most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) of
Use in Specific Populations
Based on animal data, riluzole may cause fetal harm. Women should be advised of a possible risk to the fetus associated with use of
Japanese patients are more likely to have higher riluzole concentrations, and thus may be at a greater risk of adverse reactions.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or
Please see the full
Prescribing Information for