The USFDA has recently approved an oral film formulation of rizatriptan for the acute treatment of migraine in adults and children aged 12 to 17 years. Rizatriptan is a serotonin receptor [5-HT (1B/1D)] agonist. The oral thin film contains rizatriptan benzoate as an active ingredient. The oral film’s approval is based on the positive results obtained from clinical trials with adults and pediatric patients.
Clinical trials with adults Rizatriptan benzoate orally disintegrating tablets were evaluated in two multicenter, randomized, placebo-controlled trials for efficacy in patients with a mean age of 42 years. Patients with moderate to severe headaches were randomized to receive either rizatriptan benzoate orally disintegrating tablets (10 mg) or a placebo. A higher number of patients who received rizatriptan benzoate achieved headache response two hours after treatment compared to the…
