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Axert® Approved for Adolescents

Previously approved for adult-use only, the US Federal Food and Drug Administration (FDA) has added an expanded indication for almotriptan (Axert) for adolescents aged 12 to 17.

The approval was based on a study that showed positive results in 528 adolescents with migraine. The percentage of the teens who experienced pain relief after two hours was significantly greater for those who took 6.25 mg of almotriptan than for those who took a placebo (71.8% vs. 55.3%). Other migraine symptoms, such as nausea and light and sound sensitivity, did not show a similar improvement.

Less than 5% of patients experienced side effects. The most common were dizziness, nausea, vomiting and headache. As with adults, adolescents may take a second dose after two hours if their headache returns, but should not take more than 25 mg in 24 hours.

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