In potential good news for adolescent migraineurs, the U.S. Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for Treximet, a combination medication containing sumatriptan and naproxen sodium. treximetWith the agency’s approval, Treximet would become the first sumatriptan or combination prescription medication for the treatment of acute migraine attacks with or without aura for migraineurs ages 12 to 17. Currently, Treximet is approved only for acute migraine treatment in adults. Treximet manufacturer, Pernix Therapeutics, based in Morristown, New Jersey, has indicated it expects FDA approval in the second quarter of this year. Doug Drysdale, the company’s chief executive officer, noted that Pernix is pleased to be moving ahead with the FDA approval process. “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,” he said in a company press release.

Several medications were recently deemed the most effective for treating acute migraine, including triptans, dihydroergotamine (DHE), nonsteroidal anti-inflammatory drugs (NSAIDS), butorphanol nasal spray, and the combination medication of sumatriptan/naproxen and acetaminophen/aspirin/caffein). Several other migraine medications were considered "probably effective" or "possibly effective."

OptiNoseA new device showing promise in migraine treatment is growing closer to potential approval by the United States Food & Drug Administration (FDA). The Pennsylvania-based company, OptiNose, recently announced that a pivotal phase III study evaluating the efficacy and safety of  the device, called AVP-825, will be published in the January 2015 issue of Headache, The Journal of Head and Face Pain. The study is currently available on the journal’s website through its early access feature.

Q. I had a migraine yesterday morning and took my medication to get rid of it. It got rid of my pounding pain, but about 2 hours later a portion of the right side of my face became numb. Within another 3 hours, the entire right side of my face was numb, my mouth was drooping, and my right arm and leg were heavy. As you can imagine, we thought I could be having a stroke. I am 43. We went to the emergency room, and by the time I arrived, even my speech was affected. All CT scans came back clear. The doctors decided I was having a complex migraine and explained the headaches can present as though the patient is having a stroke. They gave me a migraine "cocktail" and massive steroids and within a half hour, my symptoms were much improved. I am still regaining more control even today. What was so odd was that I had no pain.  Have you heard of this kind of migraine before?

Migraineurs who have a difficult time taking pills to alleviate their symptoms may soon be able to obtain migraine relief from a skin patch. Last month the U.S. Food and Drug Administration (FDA) approved Zecuity, a single-use, battery-powered patch that delivers sumatriptan, the most commonly used migraine medication, through the skin.

The pharmaceutical company NuPathe Inc. resubmitted its New Drug Application to the U.S. Food and Drug Administration (FDA) last month for its sumatriptan migraine patch, NP101, also known as Zelrix. It expects a six-month review by the FDA. The company had hoped to launch the patch last year, but the FDA raised concerns about its chemistry, manufacturing and safety, slowing the product’s release. The company has addressed those concerns, officials say, and is ready to move forward.

Adolescents who suffer from migraine may find relief with a combination of sumatriptan and naproxen sodium (suma/nap), according to a study published online last month in Pediatrics. Researchers studied 600 teens, ages 12 to 17, who experienced two to eight migraine attacks per month for at least six months. The first migraine during the study period was treated with a placebo. If the pain persisted two hours later, the teens were assigned to a placebo group or to a group receiving different doses of suma/nap: 10/60 mg, 30/180 mg or 85/500 mg. Researchers then evaluated who was pain-free two hours later.