Expanded Indication Approved for Tiglutik

December 13, 2019 – The U.S. FDA has approved an expanded indication for Tiglutik® (riluzole) oral suspension, manufactured by ITF Pharma. Under the expansion, the product can now be administered via percutaneous endoscopic gastrostomy (PEG) tubes to treat amyotrophic lateral sclerosis (ALS).

ALS is a disease of the motor neurons that affects approximately 16,000 individuals in the United States. As motor neurons deteriorate and die off, the brain loses its ability to send signals to the body’s muscles. This causes progressive loss of voluntary movement, which often leads to difficulty swallowing and may necessitate the placement of a PEG tube to deliver nutrients, fluids, and medications directly to the stomach.

In a clinical study, Tiglutik oral suspension was found to be bioequivalent when administered via PEG tube compared to the previously approved oral route of administration. Recommended dosing is 50mg taken twice daily at least one hour before or two hours after a meal, with 12 hours between doses. The patient’s serum aminotransferases should be monitored before and during treatment.

Tiglutik's active ingredient, riluzole, has been FDA approved to treat ALS since 1995.