Theranica, its developer, noted that it has completed regulatory submission for the device to the FDA, and that if approved, it plans to commercialize the product by the end of 2019.
Brian Grosberg, MD
Theranica, a biomedical technology developer of electroceuticals for the treatment of migraine and other idiopathic pain disorders, has announced the positive results of TCH-003, a pivotal trial (NCT03361423) of its Nerivio Migra non-invasive neuromodulation device for the acute treatment of migraine.1
Ultimately, the primary end point of pain relief at 2 hours post-treatment with the device demonstrated a 66.7% response rate in the active arm compared to 38.8% in the placebo arm (P <.0001). of the 4 secondary end points, 3 were statistically significant.
"At least 36 million Americans suffer from migraines, at various degrees. Many patients are very dissatisfied with existing medication options (mainly NSAIDs and triptans) for acute treatment of migraine pain and accompanying symptoms, due to their side effects, minimal effectiveness and/or their potential for causing medication-overuse-headache," said Morris Levin, MD, the Director of the Headache Center at the University of California in San Francisco, in a statement.
The prospective, randomized, double-blind, sham-controlled, and multi-center study assessed the efficacy, safety, and tolerability of the Nerivio Migra on 252 patients who met the International Classification of Headache Disorders, Third Edition (ICHD-3) criteria for migraine with or without aura. They were randomized 1:1 to either the active arm or placebo.
The secondary end points, which, according to principal investigator Brian Grosberg, MD, “cover all the main clinical benefits that are really important for patients,” included the percentage of patients who were pain-free at 2 hours post-treatment, the relief of the most bothersome symptom (phonophobia, photophobia, and nausea) at 2 hours post-treatment, and relief of both pain and the most bothersome symptom at 2 hours post-treatment.
In the active arm, 37.4% of patients were pain-free after 2 hours compared to 18.4% in the placebo arm (P <.004). Likewise, 46.3% of patients in the active arm reported relief of the most bothersome symptom at 2 hours compared to 22.2% of the placebo arm (P <.001). As for the relief of both pain and the most bothersome symptom, 40% of the active arm responded versus only 15.2% of the placebo arm (P <.0005).
“Statistical significance was obtained not only at post 2 hours, but also post 48 hours after the treatment, without any consumption of painkillers or migraine medications. We at the headache society, as well as our migraine patients throughout the nation, have been waiting a long time for this—a drug-free acute treatment for migraine that really works well," Grosberg, the director of the Hartford Healthcare Headache Center in Connecticut, said.
The Nerivio Migra device utilizes electrostimulation to achieve conditioned pain modulation (CPM), a stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body and can be induced anywhere, according to Theranica.
The company noted that it has completed regulatory submission for the device to the FDA and that if approved, it plans to commercialize the product by the end of 2019.
"The Nerivio Migra is targeting a very significant unmet need in treating migraines, and the study results demonstrate the significant benefit that this treatment can bring to many patients,” Levin, who also chaired the independent Data Monitoring Committee of the study, said. “Conceivably, this device has the potential to lessen the inappropriate use of opioids and barbiturates for migraine pain, and perhaps other pain conditions."
Announces Results from Pivotal Study of Device for Treating Acute Migraine [press release]. Scottsdale, AZ;
Bio-Electronics; Published November 15, 2018. prnewswire.com/news-releases/theranica-announces-results-from-pivotal-study-of-device-for-treating-acute-migraine-832012898.html. Accessed November 15, 2018.