New Oral Film Form of Riluzole Approved to Treat ALS

November 22, 2019 – The U.S. FDA has approved ExservanTM (riluzole), manufactured by Aquestive Therapeutics, to treat amyotrophic lateral sclerosis (ALS). It is the first FDA-approved riluzole product available in an oral film dosage form.

ALS is a rare group of neurological diseases that affect approximately 16,000 individuals in the United States, with an estimated 5,000 new cases diagnosed each year. The condition occurs when motor neurons responsible for muscle movement deteriorate and die off. This prevents the brain from being able to send signals to the body’s muscles, causing a loss of voluntary movement. While ALS can be inherited, the majority of cases in the U.S. are sporadic, meaning there is no known cause. In many cases, ALS is fatal within three years, though some patients have been known to survive for decades after diagnosis.

Exservan’s active pharmaceutical ingredient, riluzole, has been FDA-approved to treat ALS for more than 20 years. While riluzole does not halt the progression of ALS or ease the severity of symptoms, there is strong evidence that it can extend survival. In clinical studies, Exservan was found to perform similarly to Rilutek®, a tablet form of riluzole.

In addition to Exservan and Rilutek, riluzole is available as a generic tablet and under the brand name TiglutikTM as an oral solution (FDA approved in 2018). Of the three available dosage forms, Exservan may be a good choice for patients who have difficulty swallowing. The oral film is simply placed on the tongue and allowed to dissolve. Recommended dosing is one 50mg film taken twice a day at least one hour before or two hours after a meal. The patient’s serum aminotransferases should be monitored before and during treatment.

Aquestive has not announced launch or pricing plans.