FDA approves Celecoxib oral solution for acute treatment of migraine
The Food and Drug Administration (FDA) has approved Elyxyb an oral solution formulation of celecoxib, for the acute treatment of migraine with or without aura in adults.
Celecoxib oral solution, previously known as DFN-15, is a selective inhibitor of cyclooxygenase-2, available in a ready-made liquid solution. It is a nonsteroidal anti-inflammatory drug (NSAID) drug which is not indicated for the preventive treatment of migraine. The drug is produced by Dr Reddy''s Laboratories.
Elyxyb will be available as a clear, colorless oral solution containing 25mg of celecoxib per mL (120mg/4.8mL). The maximum dosage in a 24-hour period is 120mg.
The approval was granted on the basis of two randomized, double-blind, placebo-controlled, efficacy and safety studies to evaluate Elyxyb oral solution compared to placebo in the treatment of acute migraine in pediatric patients ages 6 to less than 18 years.The approval was based on data from 2 double-blind, placebo-controlled trials involving patients with a history of episodic migraine (2 to 8 migraine attacks per month, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks). In both studies, patients were randomized to receive Elyxyb 120mg (Study 1: n=316; Study 2: n=311) or placebo (Study 1: 315; Study 2: n=311) and were instructed to treat a migraine with moderate to severe pain intensity.
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