The FDA approved its first combination therapy to treat migraines in pediatric patients, giving its blessing to Pernix Therapeutics' ($PTX) Treximet for use in patients ages 12 to 17.
Treximet was approved for adults in 2008, and the expanded indication required a clinical trial on pediatric patients.Pernix CEO Doug Drysdale
"We are pleased with FDA's decision and look forward to bringing migraine relief to pediatric patients by making the new Treximet dose available in the third quarter of this year," said Pernix CEO Doug Drysdale in a statement. "This expanded indication exemplifies our strategy to expand the reach of our current product portfolio to address additional underserved therapeutic areas, thereby adding value for patients and shareholders alike."
The new pediatric dose will consist of a tablet containing 10 milligrams of sumatriptan and 60 milligrams of naproxen sodium, compared to the adult version containing 85 milligrams of sumatriptan and 500 milligrams of naproxen sodium. The maximum recommended dose for pediatric patients per 24-hour period is 85/500 mg.
Pernix says the approval makes the medication the first to contain sumatriptan among migraine therapies for pediatric patients. Treximet uses a patented technology developed by Pozen to combine sumatriptan with a nonsteroidal anti-inflammatory drug such as naproxen sodium.
Pozen ($POZN) says the two components are complementary because sumatriptan shrinks the swollen blood vessels in the head, while naproxen sodium inhibits the enzyme responsible for the production of mediators of pain and inflammation.
In addition, Treximet utilizes GlaxoSmithKline's ($GSK) RT technology, which accelerates the absorption of sumatriptan in the stomach. Pernix acquired the U.S. rights to Treximet last year from the pharma bigwig for an upfront payment of $250 million.
The specialty pharmaceutical company earlier this year acquired opioid pain medication Zohydro for up to $383 million. Zohydro earned the ire of those concerned about prescription drug abuse, but an abuse-deterrent formulation was recently approved (although additional data is required for it to officially don the abuse-deterrent label).
Pernix believes that Zohydro, Treximet, and sleep aid Silenor are complementary meds because they treat conditions that tend to go together, giving its sales force an edge.
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