Another existing drug is approved for pediatric migraine

A combination pill containing 10 mg of sumatriptan with 60 mg of naproxen sodium was just approved by the FDA for children aged 12 to 17. This combination in a higher dose (85 mg of sumatriptan and 500 mg of naproxen) has been available for adults for the past 7 years. This recent FDA approval allows children to take up to one adult strength tablet a day. It is good to have a smaller size tablet for kids. However, there is a big issue of cost. We don’t yet know what the pediatric strength tablet will cost, but a single tablet of the adult strength Treximet is $75. Yes, $75 for one tablet, even with a coupon you can get at GoodRx.com and $80 or more without a coupon. Very few insurance companies will pay for Treximet because you can get a generic tablet of sumatriptan (Imitrex), 100 mg for $1.50 and a tablet of naproxen, 500 mg for 7 cents. So, make-your-own Treximet will cost you $1.57. A very rare patient will tell me that they get better relief from the branded pill, which is possible because of the inactive ingredients, speed of onset and occasionally poor quality generics (I wrote about this problem in a previous post). However, such patients are very few.

Besides Treximet, we have two other triptans approved for migraines in children. Rizatriptan (Maxalt, Maxalt MLT) is approved by the FDA for children and adolescents 6 to 17 years of age and it is available in a generic form. Almotriptan (Axert) is approved in adolescents, 12 – 17 years of age, but it is available only as a branded drug ($40 a pill). In the UK, 10 mg sumatriptan nasal spray (Imitrex in the US, Imigran in the UK) was approved for adolescents, ages 12-17, who suffer from migraine and cluster headaches. In the US, we have only 5 and 20 mg nasal sprays of sumatriptan, and both are available in a generic form. Sumatriptan and zolmitriptan (Zomig, Zomig ZMT – orally disintegrating tablet, Zomig NS – nasal spray) were also tested in kids. The reason these two drugs were not approved is because the placebo response in kids tends to be very high and the active treatment was not distinguishable from placebo. This is mostly because headaches in children tend to be shorter in duration and the headache goes away on their own in a couple of hours, making it difficult to separate the active drug from placebo. However, they are probably as effective and as safe as the triptans approved in pediatric patients.