eNeura has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its sTMS for acute treatment and prevention of migraine in children 12 years of age and older.
The marketing clearance allows eNeura to market the product, which has till now been used for treating adults, for children. The FDA clearance for treating migraine in adults was received in 2017.
Single-pulse Transcranial Magnetic Stimulation (sTMS) is a non-invasive, prescription-only device that uses a mild electric current that modulates nerve cells in the brain. This is a safe, non-invasive technology that can interrupt the brain hyperactivity associated with migraine.
Treatment with portable, patient-controlled sTMS device is painless, easy and takes just a few seconds. The device must be placed at the back of the head and by pushing the button, a focused magnetic pulse for treating migraine attack and or to prevent the onset of future migraine attacks.
Clinical trials have shown that sTMS is as effective as migraine medications but without the risks or unwanted side effects associated with them.
The company claims that more than four million children, 12 years and older, suffer from migraine headache in the US and more than 36 million people in the US suffer from migraine headache.
eNeura president and CEO David Rosen said: “The clearance of our sTMS product for both acute treatment and prevention of migraine in children as young as 12 years old is a breakthrough for migraine headache patients in the U.S. Until now, children have had very few safe and effective options for the treatment and prevention of migraine. Typically, migraine patients, including children, have had to use combinations of pharmaceutical products, each with potentially unpleasant and often disabling side-effects, to prevent headache and treat acute headache attacks.
“sTMS is now labeled to address the entire spectrum of migraine with an easy-to-use device, that in multiple clinical studies, has proven to be safe and effective.”
The label expansion to include children 12 years of age and older was supported, in part by FDA’s review of the company’s ESPOUSE Study, which was conducted in adult patients at eight leading US Headache Centers.
During daily usage, about 46% of patients reported at least 50% reduction in headache attacks, while no serious adverse events were reported during the study.