Tiglutik Approved for ALS
September 5, 2018 – The U.S. FDA has approved Tiglutik™ (riluzole) oral suspension, manufactured by ITF Pharma, to treat amyotrophic lateral sclerosis (ALS).
Although the active ingredient, riluzole, has been available in tablet form in the United States since 1995, many patients who have ALS also experience difficulty swallowing. Tiglutik is the first oral suspension form of the drug. Other treatments for ALS require injections, or may need to be compounded into an oral suspension form from their standard tablet form.
Tiglutik’s recommended dosing is 50mg taken every 12 hours, at least one hour before or two hours after a meal. Healthcare providers should monitor patients’ serum aminotransferases during treatment, as the product can cause liver damage.
ITF Pharma has launched Tiglutik at a wholesale acquisition cost (WAC) of $3,150 for a 30-day supply.