The U.S. Food and Drug Administration (FDA) approved Tiglutik as a treatment for amyotrophic lateral sclerosis in 2018. It was initially indicated for oral administration only, but its label was expanded in 2019 to enable administration via a PEG tube, or a feeding tube placed through the belly into the stomach.
Amyotrophic lateral sclerosis (ALS) is a progressive disease in which symptoms continue to worsen over time. Tiglutik and other riluzole-based medications can prolong the time to needing a tracheostomy (a tube in the neck to help with breathing) and/or extend survival in some patients, but these therapies will generally not reduce existing ALS symptoms.
A clinical trial that supported Tiglutik’s approval, which tested the tablet formulation Rilutek, found evidence of a significant extension in the time to needing a breathing tube in the neck or death one year after treatment initiation. But because each patient will have a different disease experience, each person’s treatment response also will be unique.
There is no known interaction between Tiglutik and alcohol. However, because alcohol can cause liver damage, which is also a known side effect of riluzole-based medications, patients are advised to talk with their healthcare team to understand when and how much alcohol is safe for them to drink.