US regulators have issued a green light for the use of Pernix Therapeutics’ Treximet for the treatment of acute migraine in children aged 12 years and above.
According to the company, Treximet, which has been on the US market since 2008 for adults, is the first approved combination prescription medicine - and the first to contain sumatriptan - for migraine attacks in paediatric patients.
Approval was issued on the back of pivotal Phase III safety and efficacy clinical trial, plus long-term safety and pharmacokinetic data, showing the combination to be significantly more effective than placebo in treating migraine in this patient population.
A favourable safety profile was also observed in the trial, though Treximet, which is formulated with Pozen and GlaxoSmithKline technologies, does carry a boxed warning noting cardiovascular and gastrointestinal risks.
Pernix is hoping that availability of the drug will help address unmet medical need. An estimated 8% to 23% of all paediatric patients 11 years and older suffer from migraine, but treatment options are limited, especially compared to adults, it said.