Pernix Therapeutics Holdings has obtained approval from the US Food and Drug Administration (FDA) for its Treximet (sumatriptan and naproxen sodium) for use in paediatric patients aged 12 years and older to treat migraine with or without aura.
Treximet has been formulated with Pozens’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) RT technology.
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In 2008, the company first received FDA approval for Trexime as an acute treatment of migraine in adults.
Pernix chairman and CEO Doug Drysdale said: "We are pleased with FDA’s decision and look forward to bringing migraine relief to paediatric patients by making the new Treximet dose available in the third quarter of this year.
"This expanded indication exemplifies our strategy to expand the reach of our current product portfolio to address additional underserved therapeutic areas, thereby adding value for patients and shareholders alike."
The latest approval was based on pivotal Phase III safety and efficacy clinical trial and long-term safety and pharmacokinetic data.
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By GlobalDataAccording to Pernix, both demonstrated that Treximet is significantly effective than placebo in treating migraine in paediatric patients and has a favourable safety profile similar to that of Treximet for adults.
Pernix noted that the recommended dose for paediatric patients 12 years of age and older is a single tablet of Treximet 10mg/60mg (sumatriptan 10mg and naproxen sodium 60mg) per 24-hour period and the maximum recommended dose is 85mg/500mg per 24-hour period.
