ITF Pharma Announces Availability Of TIGLUTIK™ (riluzole) Oral Suspension For The Treatment Of Amyotrophic Lateral Sclerosis (ALS) In The United States
BERWYN, Pa., /PRNewswire/ -- ITF Pharma, a U.S.-based specialty pharmaceutical company and a subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, announced today the U.S. availability of its first commercial product, TIGLUTIK™ (riluzole) oral suspension, for the treatment of amyotrophic lateral sclerosis (ALS). ALS, also commonly known as Lou Gehrig's disease, is a rare disease that affects nerve cells that are responsible for controlling muscle movement.
"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. 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 Terry Heiman-Patterson, MD, director, Center for Neurodegenerative Disorders, professor, Lewis Katz School of Medicine at Temple University in Philadelphia, PA.
ITF Pharma has begun offering TIGLUTIK in the U.S. through its highly-specialized field sales team. ITF Pharma is providing comprehensive patient support services and has partnered with a full-service specialty pharmacy, to help people living with ALS receive TIGLUTIK quickly and with ease by assisting with authorizations, commercial insurance claims and benefits. While out-of-pocket costs will vary depending on insurance status, ITF Pharma's co-pay program may be able to help.
"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, chief executive officer 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 FDA approval of TIGLUTIK was based on bioavailability studies comparing oral riluzole tablets to TIGLUTIK oral suspension. TIGLUTIK was approved by the U.S. Food and Drug Administration on September 5, 2018 and has been granted orphan drug designation in the U.S. TIGLUTIK is approved in six European countries, where it is marketed under the name TEGLUTIK.
About Amyotrophic Lateral Sclerosis (ALS)
About TIGLUTIK™ (riluzole) Oral Suspension
Important Safety Information
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.
About ITF Pharma
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i AM Dyer and A Smith. Riluzole 5 mg/mL oral suspension: for optimized drug delivery in amyotrophic lateral sclerosis. Drug Des Devel Ther. 2017; 11: 59–64.
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SOURCE ITF Pharma