ZOMIG 2.5 mg and 5.0 mg tablets, an oral medication for the treatment of acute migraine with or without aura in adults, has been approved by the FDA.
In the ZOMIG clinical program which included eight placebo and non-placebo controlled clinical trials, and a one year open label safety study enrolling more than 4,700 patients, the safety and efficacy of ZOMIG was assessed. In the five placebo-controlled trials, results showed that ZOMIG provided headache relief two hours after treatment significantly more often than placebo.
Adverse events reported by patients were mostly mild or of moderate intensity and the most common included asthenia (lack of energy), nausea, dizziness, somnolence (drowsiness), and paresthesia (feelings such as tingling, numbness, or itching).
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