Based on the anticipated Prescription Drug User Fee Act (PDUFA) action date, the FDA approval is expected in the second quarter of 2015.
The sNDA was based on the safety and efficacy data sets from three trials conducted to evaluate the pharmacokinetic, efficacy, and long-term safety of Treximet for the acute treatment of adolescent migraine.
Pernix Therapeutics chief executive officer Doug Drysdale said: "We believe that Treximet has the potential to make a meaningful difference in the lives of adolescent migraine patients, and we look forward to continuing to work with the FDA in its review of the Treximet sNDA."
So far, there is no sumatriptan or combination prescription medication to treat acute migraine attacks with or without aura approved for use in this population.
Currently, Treximet is approved in the US for the acute treatment of migraine with or without aura in adults.
Treximet is formulated with Pozen’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) RT Technology.