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.