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FDA Approves Diclofenac Potassium Oral Solution for Migraine
NEW YORK -- June 22, 2009 -- The US Food and Drug Administration (FDA) has approved a diclofenac-based non-steroidal anti-inflammatory drug (NSAID [Cambia]) combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.
In randomised trials, the drug was shown to be effective not only in migraine pain, but also in treating photophobia, phonophobia, and nausea commonly associated with migraine attacks. It was also shown to provide statistically significant onset of relief of migraine pain within 15 to 30 minutes.
Most common adverse reactions were nausea and dizziness.
SOURCE: Kowa Pharma
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