St. Jude Medical says it is seeking European regulatory permission to sell a device that somewhat alleviates migraine headaches. Yes, “somewhat” as initial testing has fallen short of the FDA’s overall goals, but even so, a quarter of the group experienced a decrease in headaches.
The future of the device in the U.S. market remains unclear, because in tests the experimental, implantable device didn’t reduce pain levels by the amount required by the U.S. Food and Drug Administration (FDA.)
St. Jude, based in Little Canada, said that a study of 157 patients with serious recurring migraine headaches found that, among those treated, there was about a 27% decrease in headaches. However, patients in the study didn’t meet the FDA’s requirement of a 50% reduction in pain from migraines.
Patients in the study were asked to define their headache relief as excellent, good, fair, uncertain, or poor. At the 12 week end point, 53% of patients in the active group ranked their relief as excellent or good compared to 17% in the placebo group.
Statistical significance was demonstrated across most measures. It was not however observed in the primary endpoint as established by the U.S. Food and Drug Administration. This was defined as a significant difference between active and placebo groups who reported a 50% reduction in pain as measured on a visual analog scale and a minimum 10% point difference between the 95% confidence intervals comparing the active and placebo groups. A statistically significant difference between the active and placebo groups was observed at the 40% reduction in pain level.
The device treats migraines by stimulating nerves at the base of the head with electrical pulses, which seems to block pain signals from reaching the brain, St. Jude said. There are currently few treatments for people who suffer serious recurring migraine headaches.
Stephen D. Silberstein, M.D., past president of the American Headache Society, director of the Jefferson Headache Center, and the principal investigator in the study said:
“Many migraine patients have exhausted all current treatment options and often are disabled by the pain and frequency of migraine attacks. Achieving a reduction in the number of days they suffer from headache and a significant improvement in their quality of life may be even more important than pain reduction alone. This research demonstrates that peripheral nerve stimulation can ease the suffering of chronic migraine patients.”
According to the World Health Organization (WHO), 10% of adults worldwide suffer from migraine, a disabling condition that can last for hours or days at a time. WHO also estimates 1.7 to 4% of adults have headaches on more than 15 days per month. In the U.S. alone, it is estimated that almost 28 million Americans suffer from migraine, or roughly 13% of the population, according to the National Headache Foundation. The severity of each migraine attack can vary widely, with typical symptoms ranging from sensitivity to light, noise and motion, to nausea and vomiting in addition to headache.
Source: St. Jude Medical
Written by Sy Kraft