ITF Pharma Announces Availability Of TIGLUTIK™ (riluzole) Oral Suspension For The Treatment Of Amyotrophic Lateral Sclerosis (ALS) In The United States

BERWYN, Pa., Oct. 15, 2018 /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)
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive, ultimately fatal neurodegenerative disease, marked by a gradual degeneration of nerve cells of the central nervous system that control voluntary muscle movement.ⁱ According to the ALS Association and based on U.S. population studies, a little over 5,000 people in the U.S. are diagnosed with ALS each year. It is estimated that more than 20,000 Americans have the disease at any given time. The incidence of ALS increases with age, typically starting in the 40s and continuing until around the age of 80. However, ALS can occur in people in their 20s and 30s.ⁱⁱ In ALS, the degeneration of motor neurons is characterized by muscle weakness, typically impacting arms and legs, speech, swallowing and breathing. Impairment of swallowing (dysphagia) is a feature of ALS resulting from weakness or spasticity of muscles affecting the tongue, lips, palate, jaw, pharynx, larynx and upper trunk.ⁱ

About TIGLUTIK™ (riluzole) Oral Suspension
TIGLUTIK™ (riluzole) oral suspension is indicated for the treatment of amyotrophic lateral sclerosis (ALS). TIGLUTIK is the first and only easy-to-swallow thickened riluzole liquid for ALS, and is administered orally twice-daily via a syringe. In clinical studies, the most common side effects of TIGLUTIK were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain. These are not all of the possible side effects that you may experience with TIGLUTIK. Talk to your doctor if you have any symptoms that bother you or do not go away.

Indication
TIGLUTIK (riluzole) is a prescription medicine for the treatment of amyotrophic lateral sclerosis (ALS).

Important Safety Information

• You should not take TIGLUTIK if you are allergic to any of its ingredients.
• TIGLUTIK can cause liver injury, including death. Your doctor should do blood tests to check your liver function before and during your treatment and may stop treatment with TIGLUTIK if liver function is not normal. Contact your doctor immediately if you have unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine
• Call your doctor immediately if you have a fever, cough, or difficulty in breathing while taking TIGLUTIK.
• If you miss or skip a dose of TIGLUTIK, do not take any extra doses to make up for those you missed, but take your prescribed dose at the next regularly scheduled time.
• The most common side effects of TIGLUTIK that occurred during medical studies were numbness/tingling around the mouth, weakness, nausea, decreased lung function, high blood pressure, and abdominal pain. If any side effects become troublesome, contact your doctor.
• Be sure to tell your doctor and pharmacist about all other health conditions you have and all medicines you are taking, including nonprescription products and vitamins. If you have questions, please talk to your doctor.

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.

Please click here for the full Prescribing Information.

About ITF Pharma
ITF Pharma (www.itfpharma.com) is a Pennsylvania-based, specialty pharmaceutical company committed to investing in and commercializing impactful medicines in therapeutic areas with unfulfilled needs. ITF Pharma is the U.S. subsidiary of Italfarmaco, a privately held European specialty pharmaceutical company engaged in the development of new and groundbreaking therapies. ITF's commercial portfolio includes TIGLUTIK™ (riluzole) oral suspension, the first and only thickened liquid formulation of riluzole, approved for the treatment of amyotrophic lateral sclerosis (ALS) by the U.S. Food and Drug Administration in September 2018.

Corporate and Media Relations Contacts:

ITF Pharma
Greg Thomas
+ 1 610-331-5763
[email protected]

Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
[email protected]

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.
ⁱⁱ ALS Association. About ALS; Facts You Should Know; last accessed August 28, 2018

SOURCE ITF Pharma