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Pernix Therapeutics announced the availability of Treximet (sumatriptan and naproxen sodium) 10mg/60mg. The new dosage strength is indicated for pediatric patients aged ≥12 years for the acute treatment of migraine with or without aura.
Treximet was initially approved by the Food and Drug Administration (FDA) in May 2015 for use in the pediatric population but the formulation just recently launched due to manufacturing delays. A clinical study (n=490) showed that Treximet was well tolerated and more effective in providing pain freedom at 2 hours vs. placebo in pediatric patients aged 12–17.
Treximet combines sumatriptan, a selective 5-HT 1B/1D receptor agonist, and naproxen, a non-steroidal anti-inflammatory drug (NSAID). It is the only FDA-approved combination drug containing naproxen and sumatriptan for this indication.
Sumatriptan presumably exerts its effects through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of neuropeptide release. Naproxen, an inhibitor of prostaglandin synthesis, is thought to exert its effects through a decrease of prostaglandins in peripheral tissues.
Treximet is now available as 10mg/60mg and 85mg/500mg strength tablets in 9-count bottles.
For more information call (800) 793-2145 or visit Treximet.com.
