New Migraine Treatment Approved in Adults

Celecoxib oral solution (Elyxyb) was approved for the acute treatment of migraine with or without aura in adults. The medication is the first and only FDA-approved, ready-to-use oral solution for the acute treatment of migraine with or without aura in adults. The new formulation of the nonsteroidal anti-inflammatory drug (NSAID) celecoxib features a self-microemulsifying drug delivery system that improves solubility and bioavailability, leading to faster absorption. The new celecoxib oral solution is supplied as an oral solution containing 25 mg of celecoxib per milliliter (120 mg/4.8 mL) and is a product of BioDelivery Sciences International.

The FDA’s approval was based on data from two double-blind, placebo-controlled trials that included patients with a history of episodic migraine. Results from both studies showed that a significantly greater proportion of patients treated with celecoxib oral solution achieved freedom from pain and most bothersome symptom at 2 hours post dose compared with those treated with placebo. Following administration of 120 mg of celecoxib oral solution under fasting conditions, the median time to peak concentration was observed to be 1 hour.

The most common adverse reaction reported in the clinical trials of celecoxib oral solution was dysgeusia. The drug carries a Boxed Warning, like other NSAIDs, related to the risk of serious cardiovascular and gastrointestinal adverse events. Consult labeling for full prescribing information.

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