Migraine Abortive Treximet Approved by FDA for Adolescents

Patient Expert
Medically Reviewed

For children and adolescents with migraine, the choices available for acute migraine treatment have been even more limited than the choices available for adults. There are far fewer treatments approved by the FDA for children and adolescents than for adults. One reason for that is the logical reluctance to perform clinical trials of new medications with children and adolescents. Researchers have long been reluctant to do trials with them because of not wanting to take any risks with them.

The good news for adolescents with migraines and their parents is that they now have another FDA approved option. Treximet has been approved by the FDA for use by adolescents, 12-years-old and older, for the acute treatment of migraine with aura or migraine without aura.

Dr. David Watson, director of the headache center at West Virginia University, commented:

"This is good news for adolescents and their parents. As we all know, each acute medication doesn't work for everybody.  So the more options available the better."

Treximet is a combination of the migraine abortive sumatriptan (brand name Imitrex) and naproxen sodium. The approval follows FDA review of a phase 3 safety and efficiency clinical trial and long-term safety and pharmacokinetic data that demonstrated Treximet to be significantly more effective than placebo in treating migraine in pediatric patients. The data also showed Treximet to have a favorable safety profile similar to that of Treximet when used by adults. Treximet was approved by the FDA for use by adults in 2008.

This new indication for Treximet means that there are three triptans approved for adolescents over the age of 12 and just one approved for children as young as six years old. In December of 2011, the FDA approved the triptan Maxalt (rizatriptan) for use in children and adolescents ages six to 17 years old. Axert (almotriptan) was approved for adolescents ages 12 to 17 years old in June of 2009.

While this is good news for children, adolescents, and their parents, the fact remains that FDA approved acute migraine treatments for younger migraine patients are still quite limited. The approval of Treximet gives them a third option, but it's what I call a "me too" option since it's another triptan rather than a different family of medication. This still leaves this age group with far fewer options than adults and isn't of much significance for those who cannot use triptans and those for whom triptans don't work.

More Helpful Information:


Press Release. "FDA Approves Treximet *sumatriptan and naproxen sodium) for Use in Pediatric Patients. Morristown, New Jersey. Pernix Therapeutic Holdings, Inc. May 15, 2015.

Live well,

PurpleRibbonTiny Teri1

_Please join us for the 2015 AHMA Patient Conference on June 21, 2015. _