Subjects ” Neuromuscular Diseases
Exservan ™ (riluzole oral film) is now available for the treatment of amyotrophic lateral sclerosis (ALS).
The approval was based on pharmacokinetic studies demonstrating the bioequivalence of oral Exservan Film with oral riluzole tablets. The mechanism by which riluzole exerts its therapeutic effects in ALS patients is unknown, but clinical studies have shown that it modulates glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.
In terms of safety, the most commonly reported side effects during treatment are oral hypoesthesia, asthenia, nausea, decreased lung function, high blood pressure, and abdominal pain. The use of Exservan is not recommended in patients with baseline increases in serum aminotransferases more than 5 times the upper limit of normal; Serum aminotransferases should be measured before and during treatment.
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Exservan is available through a single specialty pharmacy, PANTHERx Rare Pharmacy. Each oral film contains 50 mg riluzole and is supplied as a single sachet or in a 60-pack. The mouth film is applied to the tongue, where it adheres and dissolves. Treatment should take place at least 1 hour before or 2 hours after a meal.
“Many people with ALS have or will have difficulty swallowing some medications. I’ve even heard of some patients crushing pills to take their medication, ”said Gary L. Pattee, MD, a neurologist and ALS specialist from Lincoln, Nebraska. “Alternative formulations of riluzole can play an important role in the treatment plan for people with ALS, including those who have difficulty swallowing some drugs.”
References
- Mitsubishi Tanabe Pharma America announces that Exservan ™ (riluzole) is now available in the US for the treatment of ALS. [press release]. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc .; 06/30/2021.
- Exservan ™ [package insert]. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc .; 2021.
This article originally appeared on MPR
Subjects:
Amyotrophic lateral sclerosis treatments for neuromuscular diseases
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