FDA approves Elyxyb for acute treatment of migraine.- Dr. Reddy’s Labs

Dr. Reddy’s Laboratories Ltd. announced approval of Elyxyb (celecoxib oral solution 25 mg/mL) by the FDA. Elyxyb, previously known as DFN 15, is indicated for the acute treatment of migraine with or without aura in adults. Dr. Reddy is working to commercialize this product through partners. Elyxyb is an oral solution of celecoxib formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption. This allows for administration of a lower dose without affecting bioavailability. In pivotal studies, Elyxyb demonstrated a rapid onset of action which is critically important to patients suffering from acute migraine attacks. The results from pivotal studies with Elyxyb established efficacy of celecoxib in the treatment of migraine with very few adverse events. For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options.