The FDA has approved Theranica’s remote electrical neuromodulation device for migraine prevention, Nerivio.
Nerivio has been approved by the FDA as a dual-use acute and preventative treatment for migraines in patients 12 and older, with or without aura.
The treatment is non-pharmaceutical, self-administered, and managed by smartphone. Nerivio is worn on the upper arm and activates peripheral nerves via painless remote electrical modulation (REN). In this manner, the gadget causes conditioned pain modulation (CPM) in distant body locations. This type of treatment session is 45 minutes long.
Nerivio is advised to be used every other day for migraine prevention or at the onset of an episode for acute therapy.
The FDA approval is based on a controlled clinical trial in which REN reduced the number of migraine days per month by 4.0 days, compared to merely a reduction of 1.3 days in the placebo group. Among patients with episodic migraine — headaches occurring fewer than 15 days per month – REN reduced migraine days by 2.3%.
Also, the medication reduced chronic migraine by three days per month. This form of migraine is defined by headaches occurring at least 15 times per month, with migraine symptoms occurring at least 8 times per month.
The journal Headache published a study with 248 participants, 85.9% of whom were female. The authors of the study found that REN is a safe and effective alternative to pharmaceutical migraine preventive therapy.
“The trial data demonstrates that Nerivio can now cover the full treatment spectrum and provide access to migraine prevention and relief, particularly for adolescents who have a strong preference for clinically effective, drug-free treatment solutions,” says Andrew Blumenfeld, M.D., director of the Los Angeles Headache Center and co-author of the paper.
