Exservan (riluzole oral film) is a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neurological disease characterized by the degeneration and death of motor neurons that control voluntary muscle movements.
When motor neurons die, muscles lack nerve signals that “tell” them to contract and, as a result, they become weak and atrophy. This leads to severe disability including difficulty in swallowing, which complicates the ingestion of oral tablets and suspensions.
Exservan was developed by Aquestive Therapeutics using its novel PharmFilm technology. It’s an orange film containing a 50 mg riluzole dose that is taken twice a day by placing it on the tongue. It dissolves automatically and requires no water. Exservan is marketed by Mitsubishi Tanabe Pharma America in the U.S. and by Zambon Pharma in the European Union.
How Exservan works
Although the exact mechanism of action of riluzole is not known, it is thought to delay the symptoms of ALS by blocking the action of glutamate, a neurotransmitter or chemical messenger that is released by nerve cells to transmit nerve signals.
Excessive glutamate leads to the degeneration and death of nerve cells that control voluntary muscle movements in ALS patients. Riluzole reduces glutamate release by nerve cells and thereby slows down the neurological deterioration and its associated symptoms.
Exservan in clinical trials
No clinical trials have specifically tested the safety and efficacy of Exservan in healthy volunteers or ALS patients. Its safety and efficacy parameters are based on clinical trials that were conducted using oral riluzole tablets that showed improved symptoms and survival in ALS patients.
Aquestive Therapeutics conducted tests to compare the pharmacokinetic profile (movement in the body) of Exservan with that of Rilutek in healthy volunteers. The results of these tests showed that Exservan had a similar pharmacokinetic profile to Rilutek and was as safe as Rilutek. This was the basis of the FDA approval of Exservan.
The most common adverse reactions associated with Exservan include reduced sensation or numbness in the mouth, lack of energy or general weakness, nausea, decreased lung function, hypertension, and abdominal pain.
Last updated: Nov. 27, 2019
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