Tiglutik, Liquid Form of Riluzole, Now Available in US for ALS Treatment

Tiglutik, an oral suspension of riluzole, is now available as a treatment for amyotrophic lateral sclerosis (ALS) in the U.S., ITF Pharma, the therapy’s developer and a subsidiary of Italfarmaco, recently announced.

Rilutek (riluzole, marketed by Sanofi), has been available in the U.S. as 50 mg tablets since December 1995. ALS patients, however, can experience dysphagia — difficulties in swallowing — a consequence of muscle weakness or spasticity in the tongue, lips, palate, jaw, pharynx, larynx, and upper trunk.

“Riluzole was the first treatment to slow the progression of ALS and has been the gold standard for more than 20 years. ALS, a neurodegenerative disease that has no cure, results in progressive weakness leading to difficulties in swallowing for more than 80% of affected individuals,” Terry Heiman-Patterson, MD, director of the Center for Neurodegenerative Disorders at Temple University in Philadelphia, said in a press release.

Tiglutik is a thickened liquid formulation of riluzole (5 mg/mL), administered twice daily via an oral syringe, and is intended to be easier for patients to swallow.

“The availability of TIGLUTIK, a thickened liquid preparation of riluzole, will allow continued ease of administration when a patient can no longer swallow the pills. This will enable people living with ALS to continue to take riluzole throughout the course of their illness and minimizes the difficulties and time related to crushing pills into liquid. Not only that, dosing will be more accurate and the ease of using an already liquid medicine will improve compliance,” said Heiman-Patterson, who is also a professor at Temple’s Lewis Katz School of Medicine.

To help ALS patients get Tiglutik quickly and easily, ITF Pharma has partnered with a full-service specialty pharmacy to assist with authorizations, commercial insurance claims, and benefits.

While the costs of the therapy to ALS patients will vary depending on the type of insurance, ITF Pharma has developed a copay program to help those in need get the therapy promptly.

“ITF Pharma is proud to bring TIGLUTIK, the first and only easy-to-swallow thickened riluzole liquid, to the ALS community in the U.S.,” said Denny Willson, CEO of ITF Pharma. “The commercial availability of TIGLUTIK reflects the hard work of many dedicated individuals within the company and represents an important milestone in ITF’s growth and evolution as a company committed to taking risks for patients by investing in therapies in treatment areas with unfulfilled needs.”

The U.S. Food and Drug Administration approved Tiglutik in September, after reviewing data comparing it with the riluzole tablets.

Tiglutik is approved in six European countries, including the U.K., where it is sold as Teglutik and marketed by Martindale Pharma.