Exservan™ (riluzole oral film) is now available for the treatment of amyotrophic lateral sclerosis (ALS).
The approval was based on pharmacokinetic studies demonstrating bioequivalence of Exservan oral film to oral riluzole tablets. The mechanism by which riluzole exerts its therapeutic effects in ALS patients is unknown, however clinical studies have shown that it modulates glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.
Regarding safety, the most common adverse reactions reported with treatment include oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain. The use of Exservan is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times the upper limit of normal; serum aminotransferases should be measured before and during treatment.
Exservan is available through a single specialty pharmacy, PANTHERx Rare Pharmacy. Each oral film contains 50mg of riluzole and is supplied as a single pouch or in a 60-count carton. The oral film is applied on top of the tongue where it adheres and dissolves. Treatment should be administered at least 1 hour before or 2 hours after a meal.
“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, MD, a neurologist and ALS specialist based in Lincoln, Nebraska. “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.”
- Mitsubishi Tanabe Pharma America announces Exservan™ (riluzole) is now available in the U.S. for the treatment of ALS. [press release]. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; June 30, 2021.
- Exservan™ [package insert]. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2021.