25 Jun, 2021, 09:00 ET
JERSEY CITY, N.J., June 25, 2021 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced PANTHERx Rare Pharmacy has been selected as the exclusive provider of specialty pharmacy services for EXSERVAN™ (riluzole), an oral film formulation of riluzole for the treatment of amyotrophic lateral sclerosis (ALS).
"As we explored options for specialty pharmacy partners for the distribution of EXSERVAN, it was important to find an organization with specific knowledge and experience that could best support the ALS community," said Kevin O'Brien, Vice President of Market Access, MTPA. "PANTHERx is able to deliver on both fronts, in addition to also having an unwavering dedication to patients. This is closely aligned with our commitment to helping patients."
Once a patient is prescribed EXSERVAN, they may be enrolled in access information services. Upon enrollment, PANTHERx will provide patients with a review and summary of insurance benefit options, including information about eligibility for the Out-of-Pocket Assistance Program for EXSERVAN.
MTPA plans to make EXSERVAN available to patients by the end of June 2021.
"PANTHERx prides itself on being focused on people living with the implications of rare disease," said Rob Snyder, President of PANTHERx. "We hope our extensive experience will positively impact the members of the ALS community that we aim to serve through our dispensing of EXSERVAN. We look forward to working with MTPA to help address the needs of people impacted by this devastating disease."
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.
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.
Overview of Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan's pharmaceutical industry. With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company with one of the longest histories of pharmaceutical companies in Japan.1 In accordance with the corporate philosophy of "contributing to the healthier lives of people around the world through the creation of pharmaceuticals," the Company formulated the key concept of Open Up the Future under the Medium-Term Management Plan 2016-2020. Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas — immune-inflammation diseases, diabetes and kidney, central nervous system, and vaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA. 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 Research by TOKYO SHOKO RESEARCH, LTD.
SOURCE Mitsubishi Tanabe Pharma America, Inc.
Share this article