Medication Monitor

Generic Name (Trade Name—Company)
November 26, 2019

Riluzole oral film

(Exservan—Aquestive Therapeutics)
Riluzole oral film approved for patients with ALS

Aquestive Therapeutics announced FDA approval of riluzole oral film for treatment of amyotrophic lateral sclerosis (ALS). It can be administered without water to patients with ALS who have trouble swallowing. According to Aquestive, studies have demonstrated riluzole's pharmacokinetic bioequivalence to the reference listed drug, Rilutek.

The recommended dosage is 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal. 

Common adverse reactions are oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain.