FDA Approves Percutaneous Endoscopic Administration of Riluzole for Treating ALS

The Food and Drug Administration (FDA) has approved administration of riluzole oral suspension (TIGLUTIK; ITF Pharma Inc., Berwyn, PA) via percutaneous endoscopic gastronomy (PEG) tube for treating amyotrophic lateral sclerosis (ALS). The FDA approval is based on a study that showed the therapy is bioequivalent when administered orally or intragastrically via PEG tubes.  

Although the mechanism of action of riluzole is not fully understood, in clinical studies it has modulated glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling. 

The supplemental new drug application (sNDA) approval expands the population who will benefit from the therapy to include those whose swallowing difficulty makes achieving good nutrition difficult and the use of a PEG feeding tube necessary. Swallowing difficulties (dysphagia) occurs eventually in 85% of all people with ALS.  

“There are many medical and quality-of-life advantages for the use of a PEG feeding tube as an individual’s ALS progresses, including the ability to maintain more adequate hydration, administer medications, and potentially reduce the risk of choking and aspirating when oral ingestion becomes too challenging,” said Benjamin Rix Brooks, MD, medical director at the Carolinas Euromuscular/ALS-MDA Center. “This expanded use for TIGLUTIK provides an alternate administration route for the majority of people with ALS who choose to undergo this procedure.”