Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Neurology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved November 1997
Treatment Area: migraine
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).