Mitsubishi Tanabe Pharma America Announces EXSERVAN™ (riluzole) is Now Available in the U.S. for the Treatment of ALS
JERSEY CITY, N.J., June 30, 2021 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that EXSERVAN™ (riluzole), the first oral film formulation of riluzole, is now available in the U.S. for the treatment of amyotrophic lateral sclerosis (ALS). EXSERVAN, which dissolves on top of the tongue, was developed to help meet the needs of people with ALS, including those who have difficulty swallowing some medications.1,2,3
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"People with ALS can develop difficulty swallowing, affecting how certain medications are administered," said Atsushi Fujimoto, President, MTPA. "Patients are the primary focus of our work as we try to make a difference, and we are pleased to bring this new option to those suffering from this devastating and progressive disease."
The U.S. Food and Drug Administration (FDA) approved EXSERVAN in November 2019 based on a pivotal bioavailability and bioequivalence study to bridge the safety and efficacy of the new oral film formulation to the approved tablet dosage form of riluzole. EXSERVAN was shown to deliver a similar amount of medication throughout the bloodstream as the riluzole tablets.3 Riluzole was approved by the FDA in 1995 for the treatment of ALS and showed that the time to tracheostomy or death was longer for patients receiving riluzole tablets compared to placebo.4,5
"Many people with ALS have or will experience difficulty swallowing some medications. I have even heard of some patients crushing tablets to take their medicine," said Gary L. Pattee, M.D., a neurologist and ALS specialist based in Lincoln, Neb. "Alternative formulations of riluzole can play an important role in the treatment plan for people with ALS, including those who have difficulties swallowing some medications. This is exciting news for the ALS community."
EXSERVAN oral film (50 mg each) dissolves on the top of the tongue and is taken twice a day without liquids or food. The treatment should be taken at least one hour before or two hours after a meal. Patients and caregivers should carefully read the "Instructions for Use" on how to properly take EXSERVAN oral film.
Access to EXSERVAN is available through a single specialty pharmacy, PANTHERx Rare Pharmacy. Treatment with the medication is initiated by a healthcare provider (HCP) by submitting a Prescription and Enrollment Form to PANTHERx. Patients are then contacted by the specialty pharmacy to review insurance benefits and product dispensing. PANTHERx also is able to enroll eligible patients in the EXSERVAN Out-of-Pocket Assistance Program. PANTHERx can be contacted at 1-855-743-9275.
Patients prescribed EXSERVAN through the Department of Veterans Affairs, the Department of Defense, other federal institutions and certain integrated delivery networks do not need to coordinate via PANTHERx, they should obtain the therapy through their healthcare providers as with their other medications.
For more general information about ALS and EXSERVAN, please call 1-855-457-6968 to speak with a JourneyMate™ specialist.
About EXSERVAN™ (riluzole) oral film
IMPORTANT SAFETY INFORMATION
Before using EXSERVAN, tell your doctor about all the medicines you take and all your health conditions, including if you:
EXSERVAN can cause serious side effects, including:
Liver Problems: Cases of liver injury, some fatal, have occurred in patients taking riluzole. Consult your doctor promptly if you experience unexplained nausea, vomiting, stomach (abdominal) pain, fatigue, weight loss (anorexia), jaundice (yellowing of the skin or whites of the eyes), and/or dark urine.
Low White Blood Cell Counts (Neutropenia): Tell your doctor if you develop a fever while taking EXSERVAN.
Serious Lung Problems (Interstitial Lung Disease): Tell your doctor if you have problems with your lungs or breathing such as dry cough and difficult or labored breathing. Discontinue EXSERVAN immediately if you develop interstitial lung disease.
The most common side effects include numbness in the mouth or tongue, muscle weakness, nausea, lung problems, high blood pressure, and stomach (abdominal) pain.
These are not all the possible side effects of EXSERVAN. Consult your doctor for medical advice about side effects.
To report side effects, contact Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use EXSERVAN as prescribed. The recommended dosage for EXSERVAN is 50 mg taken orally twice daily at least 1 hour before or 2 hours after a meal. Place EXSERVAN oral film strip on the top of the tongue where it will adhere and dissolve. Swallow in a normal manner. Do not cut or split the film or take liquids with EXSERVAN. Do not chew, spit, or talk while EXSERVAN is dissolving. Read the Instructions for Use for EXSERVAN.
Please click here to see the full Prescribing Information for EXSERVAN.
About Mitsubishi Tanabe Pharma America, Inc.
About Mitsubishi Tanabe Pharma Corporation
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1 EXSERVAN™ (riluzole) Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2021.
SOURCE Mitsubishi Tanabe Pharma America, Inc.