Pernix announced that the Food and Drug Administration (FDA) has approved Treximet (sumatriptan, naproxen sodium) for use in patients aged ≥12 for the acute treatment of migraine with or without aura.

Treximet is the first combination prescription medicine and first to contain sumatriptan for the treatment of acute migraine attacks in pediatric patients. The FDA approval was based on a Phase 3 safety and efficacy clinical trial, which demonstrated that Treximet was significantly more effective than placebo in treating migraine in pediatric patients.

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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 and is already indicated for the acute treatment of migraine in adults.

The recommended dose for pediatric patients is one tablet of sumatriptain 10mg, naproxen sodium 60mg strength per 24-hour period, with a maximum recommended dose of sumatriptain 85mg, naproxen sodium 500mg per 24-hour period.

The new fixed dose of 10mg/60mg is expected to launch in the third quarter of 2015. Treximet is currently available in an 85mg/100mg fixed dose.

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