JERSEY CITY, N.J. July 8, 2024 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the decision to discontinue EXSERVAN™ (riluzole), the first oral film form of riluzole, for the treatment of amyotrophic lateral sclerosis (ALS). The decision comes after careful consideration and review of the company’s business plan.
The promotion, distribution and production of EXSERVAN will end effective September 30, 2024. People living with ALS currently taking EXSERVAN can consult with their prescribing physician to determine how to best transition to an alternative treatment plan. Riluzole remains an available treatment option from other companies.
About EXSERVAN™ (riluzole) oral film
EXSERVAN, an oral film formulation of riluzole, was approved by the U.S. Food and Drug Administration (FDA) in November 2019. EXSERVAN was developed by Aquestive Therapeutics, Inc. using its PharmFilm® innovative drug delivery technology. The oral film is placed on top of the patient’s tongue and dissolves. Under the terms of a licensing and supply deal agreement, MTPA is commercializing EXSERVAN in the U.S. and Aquestive is serving as the exclusive sole manufacturer and supplier for the product. For more information, visit www.EXSERVAN.com.
INDICATION
EXSERVAN™ (riluzole) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to riluzole or to any of its ingredients.
Before using EXSERVAN, tell your doctor about all the medicines you take and all your health conditions, including if you:
- Have liver problems.
- Are taking certain drugs known as strong or moderate CYP1A2 inhibitors such as ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, or zileuton.
- Are pregnant or intend to become pregnant during EXSERVAN therapy, or if you are breastfeeding or intend to breastfeed during EXSERVAN therapy.
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.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on X (formerly Twitter), Facebook and LinkedIn.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, “Forging the future”. MTPC sets the MISSION of “Creating hope for all facing illness”. To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on “precision medicine” to provide drugs with high treatment satisfaction and additionally working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/.
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