Mitsubishi Tanabe Pharma America Announces EXSERVAN™ (riluzole) is Now Available in the U.S. for the Treatment of ALS

New Innovative Orally Dissolving Film Designed to Help Meet the Needs of ALS Patients Who Have Difficulty Swallowing Some Medications

News provided by

Mitsubishi Tanabe Pharma America, Inc.

Jun 30, 2021, 09:00 ET

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

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8904651-mitsubishi-tanabe-pharma-america-exservan-riluzole-als/

"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
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's (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC to commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), founded in 1678, is one of the oldest pharmaceutical companies in the world. Focused on ethical pharmaceuticals, MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. In light of the anticipated changes in healthcare needs in the future, MTPC is advancing business activities under the mission of "Creating hope for all facing illness," and has set the corporate vision for 2030 (VISION 30) to "Be a healthcare company that delivers optimal therapy to each individual." As part of the vision for 2030, MTPC is prioritizing work on "precision medicine" to create effective therapies and preventive methods by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. In addition, MTPC is 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. MTPC is a member of Mitsubishi Chemical Holdings Group. For more information, go to https://www.mt-pharma.co.jp/e/.

PharmFilm^® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.

¹ EXSERVAN™ (riluzole) Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2021.
² Data on File. Mitsubishi Tanabe Pharma America, Inc., Jersey City, NJ.
³ Center for Drug Evaluation and Research (US). 2017. EXSERVAN (riluzole). Washington DC: US Food and Drug Administration, Center for Drug and Evaluation Research. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212640Orig1s000MedR.pdf. Accessed April 2, 2021.
⁴ Bensimon G, et al. New England Journal of Medicine. 1994;330:585 91.
⁵ Lacomblez L, et al. Lancet. 1996;347(9013):1431.