There is no cure for migraine headaches but a new gel treatment may help the 36 million Americans estimated to suffer with them.1 One in four households has a family member who has migraines, according to the American Migraine Association. Migraines are also three times more common in women than in men.
They also estimate that preventative practices only diminish migraines by 50 percent, in the 40 percent of people who take them. That means that newer and better treatments with low side effects will be very welcomed.
The new gel called Topofen, also known as ELS-M11, was used in a clinical trial to test its effectiveness as a treatment for migraines. It is made by Achelios Therapeutics and contains a proprietary gel formulation of 5 percent ketoprofen, a potent NSAID.
NSAIDs are used as anti-inflammatories to reduce pain and inflammation but orally, they can cause GI side effects such as irritation. In the high doses used to treat migraines, they can potentially cause ulcers and bleeding.
However, when NSAIDs are used topically as they were in this study, the risk of those side effects is much less.
A phase 2 clinical trial that was double-blind and had a placebo control group evaluated 48 adults aged 18-65 years who had a history of migraines. The participants were selected from two different U.S. centers.
Some had auras (warning signs of an impeding migraine experienced by 20 percent of migraine sufferers) and some did not, prior to their migraines.
They were instructed to apply a pea-sized gel on the skin area under which their trigeminal nerve runs on both sides of their faces, They were to do this even if they typically only had migraines on one side of their heads. They applied the gel for the next five moderate and severe migraines they experienced, and then monitored their symptoms for 24 hours.
The study found that 77 percent of the severe migraine sufferers “experienced relief of pain and migraine-associated symptoms and 45 percent had sustained pain relief from two to 24 hours compared to 15 percent of placebo,” reported Science Codex.
Also, “50 percent of the Topofen users were pain free at 24 hours compared to 25 percent of the placebo treated patients.”
The only side effect noted was some skin irritation where the gel was placed, which resolved quickly.
"This research sheds new and highly welcome light on our understanding of how severe headaches are caused by neurogenic inflammation and how we can interrupt pathologic feed-forward signaling in the trigeminal system," said lead researcher, Wolfgang Liedtke, MD, PhD, associate professor of neurology, anesthesiology and neurobiology, Duke University, Durham, North Carolina. Liedtke is also an advisor and consultant to Achelios Therapeutics.
The results of the clinical trial were presented at the Emerging Science session of the American Academy of Neurology annual meeting in Washington, D.C., on Wednesday, April 22, 2015.
There are a couple of areas worth noting. First, the study was run by Dr. Liedtke, MD, PhD, who is a paid consultant to Alegros, the maker of the medication.
The study also was not very large, under 50 participants. It will take testing on hundreds of migraines sufferers to determine if Topofen is a worthwhile treatment.
However, ketoprofen is already used as a topical drug called Voltaren gel for joint and muscle pain.
Voltaren gel is not currently FDA-approved for migraine use but if you are a migraine sufferer, talk to your doctor about trying it for your migraines to see if you receive any benefit.
Dr. Liedtke commented to Medscape that the absorption of Topofen was superior to a “reference topical ketoprofen gel” but we don’t know specifically how it compares to Voltaren.
If it provides you with some relief, perhaps the formulation of Topofen will give you better relief when it comes to market. At least in the meantime, you can test if using topical ketoprofen might be a worthy option for you to pursue.
About Migraine. American Migraine Foundation. Retrieved May 24, 2015.
TOPOFEN migraine therapy Phase II clinical trial results. Science Codex.
Retrieved May 24, 2015.
Topical Gel Promising in Migraine. Medscape Nurses. Retrieved May 24, 2015.
New York Headache Blog by Dr. Alexander Mauskop. New York Headache Blog. Retrieved May 24, 2015.
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues.
Edited by Jody Smith
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