Treximet sNDA Accepted by FDA for Adolescent Migraine

Pernix announced that its supplemental New Drug Application (sNDA) for Treximet (sumatriptan/naproxen sodium) for use in adolescents aged 12–17 years for the acute treatment of migraine with or without aura has been accepted by the Food and Drug Administration (FDA).

The sNDA filing includes safety and efficacy data from 3 trials conducted to evaluate the pharmacokinetic, efficacy, and long-term safety of Treximet in the acute treatment of migraine in adolescents. Treximet was initially approved for use in adults.

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Treximet is a combination of sumatriptan, a 5-HT1 receptor agonist, and naproxen, a nonsteroidal anti-inflammatory drug (NSAID). Sumatriptan mediates vasoconstriction of the human basilar artery and vasculature of human dura mater. Naproxen contains analgesic and antipyretic properties which may be related to prostaglandin synthetase inhibition. It is formulated with GlaxoSmithKline’s RT Technology.

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