FDA granted Theranica's De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, using remote electrical neuromodulation for the acute treatment of migraine.Theranica
Editor's note: This story was updated on July 23, 2019, to include the findings of a recently published paper.
Headache researchers in California and Missouri conducted a per-patient comparison of Theranica's Nerivio remote electrical neuromodulation (REN) device versus acute pharmacological treatments for migraine symptoms. The article, published in The Journal of Headache and Pain, compared the efficacy of the Nerivio REN device to previous acute care in the same patients. The post-hoc analysis used data from a randomized double-blind, sham-controlled pivotal study in adult migraine patients.
Usual care was the preferred treatment as identified by each individual patient in a run-in phase prior to being introduced to the REN device and included specific acute migraine medications like triptans, non-specific acute pain relief medications (prescription or over the counter), etc., and non-pharmacological treatments.
At two hours post-treatment, pain relief was achieved by 66.7% of the 99 participants following REN treatment versus 52.5% of the participants when usual care was used. Additionally, 50.0% of the participants were pain-free at two hours in at least one of two attacks following REN treatment as opposed to 36.7% when usual care was used. The study also found that REN’s efficacy is unaffected by the use of migraine preventive medications.
The Nerivio received marketing authorization in May through FDA's de novo pathway. The device is indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine. It was also one of a handful of device-based migraine treatments MD+DI featured earlier this year.
“REN is an exciting new pain relief option for migraine sufferers,” said Alan Rapoport, MD, a clinical professor of neurology at University California, Los Angeles and co-author of the study. “Additional options are needed, especially for those patients who experience challenges with efficacy, tolerability, or contraindications of medications, or medication overuse headaches. Providing the migraine patient community with safe and effective alternatives is important, and REN looks very promising.”
Theranica’s Nerivio device is worn for 45 minutes on the upper arm at the start of a migraine attack. It produces an electrical signal that stimulates the nerves and induces conditioned pain modulation, a descending endogenous analgesic mechanism that inhibits pain in remote body regions. At the same time, the stimulation on the arm remains below the perceptual pain threshold.
“Now that this innovative device has received FDA market authorization, many of my colleagues and I look forward to having it available in the market, as it has the potential to be an effective yet safe alternative treatment for many of our migraine patients,” said Robert Cowan, MD, a professor of neurology and chief of the division of headache medicine at Stanford University, who co-authored the study.
In addition to Rapoport and Cowan, another doctor who co-authored the study is Jo Bonner, MD, at the Mercy Headache Center in St. Louis, MO.
In November 2018 Theranica reported results of a prospective, randomized, double-blind, sham-controlled, multi-center study that evaluated the efficacy, safety, and tolerability of the device on 252 patients diagnosed with migraine with or without aura. The study met its primary endpoint and almost all of its secondary and exploratory results with high statistical significance. On its primary endpoint of pain relief at 2 hours post-treatment, the device demonstrated a 66.7% response rate in the active arm vs. 38.8% in the placebo group (p<0.0001). On the secondary endpoint of being pain-free at 2 hours post-treatment, the response rate was 37.4% (active) vs. 18.4% (placebo) (p<0.004).
On the secondary endpoint of relief of the most bothersome symptom (MBS) out of phonophobia, photophobia, and nausea at 2 hours post-treatment, the response rate was 46.3% (active) vs. 22.2% (placebo) (p<0.001). On the secondary endpoint of relief of both pain and the MBS at 2 hours post-treatment, the response rate was 40.0% (active) vs. 15.2% (placebo) (p<0.0005).
Alon Ironi, CEO and co-founder of Theranica, said in May that the company plans to launch the Nerivio Migra in the United States later this year. He also noted that the company is pursuing potential future indications for the device.
“We have identified at least seven different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development," Ironi said.
“Physicians who treat people with migraine are both patient-centered and science-driven,” said Stephen Silberstein, director of the Headache Center at the Jefferson University Hospital in Philadelphia, and a member of Theranica's medical advisory board. “Over the last 20 years, my colleagues and I have used triptans and ergots for acute migraine treatment. There is a large unmet need for new treatments in this population when these medications are not effective, are contra-indicated, or have non-tolerable side effects."
Silberstein also noted that triptans and most current acute migraine medications, including over-the-counter drugs indicated for migraine, are associated with medication-overuse headache, which is associated with increased frequency of migraine attacks and often results in chronic migraine.