PANTHERx® Rare Selected by Mitsubishi Tanabe Pharma America, Inc. (MTPA) as Exclusive Provider of U.S. Specialty Pharmacy Services for EXSERVAN™ (riluzole) oral film

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Jul 08, 2021, 11:02 ET

PITTSBURGH, July 8, 2021 /PRNewswire/ -- PANTHERx Rare announced today that it was selected by Mitsubishi Tanabe Pharma America, Inc. (MTPA) as the exclusive U.S. pharmacy distribution partner for EXSERVAN™ (riluzole). The drug, an oral film formulation of riluzole, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS).

"PANTHERx is excited to be supporting ALS patients who have been prescribed EXSERVAN through medication dispensing and patient education as part of our proprietary RxARECARE^® model," said Rob Snyder, President of PANTHERx.

PANTHERx utilizes technology and human capital to create RxARECARE programs tailored to the unique needs of the medications we dispense and the preferences of each patient we support.

About PANTHERx Rare
PANTHERx, part of Envolve Pharmacy Solutions, is one of the largest and fastest growing rare pharmacies in the United States. PANTHERx transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to patients afflicted with rare and devastating conditions. Although the incidence is as common as diabetes, less than 7% of the 7,000 known rare and devastating disorders have an approved therapy. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community.

PANTHERx was recently awarded Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy (NASP) and earned the inaugural Accredited Distinction in Rare Diseases and Orphan Drugs from the Accreditation Commission for Health Care (ACHC). PANTHERx is a three-time winner of the prestigious MMIT Patient Choice Award, including the 2020 honor. PANTHERx is headquartered in Pittsburgh, Pennsylvania, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.

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 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.

Contact: Allyson Ayoob, 855-726-8479 x 1142, [email protected]

SOURCE PANTHERx Rare Pharmacy