The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Tiglutik (riluzole; ITF Pharma) oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes for the treatment of amyotrophic lateral sclerosis (ALS). Previously, Tiglutik was only indicated for oral administration.
The sNDA approval was based on a study that showed Tiglutik oral suspension was bioequivalent when administered intragastrically and orally. The mechanism by which riluzole exerts its therapeutic effects in ALS patients is unknown, however clinical studies have shown that it modulates glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.
“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 to potentially reduce the risk of choking and aspirating when oral ingestion becomes too challenging,” said Benjamin Rix Brooks, MD, medical director at the Carolinas Neuromuscular/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.”
The product is available as a 50mg/10mL strength oral suspension in 300mL bottles in 2-count cartons with supplies. Both silicone and polyurethane PEG tubes can be used.
For more information visit itfpharma.com.