The FDA has approved a smartphone-controlled medical device that claims to treat migraine. Theranica, a bio-medical technology company, said its Nerivio Migra device
uses remote electrical neuromodulation for the acute treatment of migraine. It was approved through the de novo regulatory pathway.
The company said the approval is based on the results
of a prospective, randomized, double-blind, placebo-controlled, multicenter pivotal study funded by the company, in which 252 patients from 12 clinics used the noninvasive wearable to treat their migraine attacks.
In the study, the device was applied for 30 to 45 minutes on the upper arm within 1 hour of attack onset. Electrical stimulation was at a perceptible but not painful intensity level.
Migraine pain levels were recorded at baseline, and at 2 hours and 48 hours posttreatment. Most bothersome symptoms (MBS) were also recorded. The primary efficacy endpoint was the proportion of participants achieving pain relief at 2 hours posttreatment (improvement from severe or moderate pain to mild or none, or from mild pain to none). Relief of MBS and being pain‐free at 2 hours were key secondary endpoints.
Active stimulation was more effective than sham stimulation in achieving pain relief (66.7% [66/99] vs 38.8% [40/103]), being pain‐free (37.4% vs 18.4%, P
= .003), and MBS relief (46.3% vs 22.2%, P
= .0008) at 2 hours posttreatment. The pain relief and pain‐free superiority of the active treatment was sustained 48 hours posttreatment. The incidence of device‐related adverse events was low and similar between treatment groups (4.8% [6/126] vs 2.4% [3/126], P
The treatment is believed to work by stimulating upper arm peripheral nerves to induce conditioned pain modulation, an endogenous analgesia mechanism in which conditioning stimulation inhibits pain in remote parts of the body.
Among its limitations, patients had a low rate of severe baseline pain intensity and high rate of mild pain intensity. Researchers also did not study the efficacy of the device at intervention periods more than 1 hour of symptoms onset. In addition, selecting an appropriate sham device was challenging. Lastly, the placebo effect was higher than in drug trials, similar to other neuromodulation studies. The researchers said the results were “not significantly affected” by assigned treatment.
A recently released survey said patients taking acute medication for migraine still have unmet medical needs
. Estimates of the cost of migraine in the United States range from $22 billion to $28 billion or more.