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How Devices Could Tackle Migraine Pain

A recent survey revealed a significant knowledge gap between patients’ satisfaction and providers’ perceived patient satisfaction with commonly prescribed migraine treatments, as well as a lack of knowledge about non-drug migraine treatments.

  • A recent survey found a significant underutilization of non-drug treatment options for migraine among female patients and healthcare providers.

    A total of 1,005 adult females (ages 18 to 60) who have been diagnosed with migraines were surveyed about their experiences with migraine treatments, management of their symptoms, the impact of migraines on their quality of life, and knowledge of non-drug treatment options. Additionally, 402 healthcare professionals were surveyed about migraine treatments they use for patients, their perceptions of migraine patients, and their familiarity with the role of the vagus nerve in treating migraines.

    The survey, sponsored by bioelectronic medicine company electroCore and completed in partnership with HealthyWomen, showed that only 18% of patients are completely satisfied with their current migraine treatment, yet only 8% of healthcare providers say they have treated patients with a non-drug therapy.

    Perhaps even more telling is the fact that the survey revealed 86% of female migraine patients say they would be willing to try non-drug treatment options, while only 28% of healthcare providers said their patients would be willing to try non-drug treatments. These findings reveal a crucial knowledge gap between patients’ satisfaction and providers’ perceived patient satisfaction with commonly prescribed migraine treatments, as well as a lack of knowledge about non-drug migraine treatments.

    "The survey is a clear indication from the marketplace that there are a considerable amount of demand and folks out there that are looking for non-drug alternatives to manage pain conditions, especially migraine and cluster headache," electroCore CEO Frank Amato told MD+DI.

    Current medications available to patients who suffer from migraines or cluster headache are inadequate in their efficacy, Amato said, and a lot of them have side effects or contraindications for cardiovascular events.

    "Folks are just dissatisfied with the current treatment options," he said.

    In the following slides, we highlight several devices, including electroCore's gammaCore Sapphire, that are either on the market or in development to tackle migraine and/or cluster headache.

  • Basking Ridge, NJ-based electroCore received FDA 510(k) clearance in November 2018 for an expanded label for its gammaCore non-invasive vagus nerve stimulator (nVNS) therapy for adjunctive use for the preventive treatment of cluster headache in adult patients. The device is the only product of its kind with FDA clearance for the prevention of cluster headache. That clearance followed the launch of the company's second-generation device, the gammaCore Sapphire, by just a few months.

    The gammaCore Sapphire can be used multiple times throughout the day, Amato said. Having access to a non-drug therapy as both a preventative measure and to acutely treat breakthrough headaches when they occur is one of the many benefits of the electroCore Sapphire, he said. Additionally, if the device alone isn't enough to tackle the pain, it can be used in conjunction with traditional headache medication without the concern of a drug-to-drug interaction.

    "The benefits go to flexibility in dosing, the amount of therapy available, and lastly the flexibility of utilizing multiple different options for the patient," Amato said.

    The device is available by prescription and is delivered via mail to the patient's home from a specialty pharmacy.

    Amato compared the device to a cell phone in that it fits in the palm of the patient's hand. To administer the therapy, the patient puts a little bit of conductive gel on the stimulation surfaces of the device and then places the device against their vagus nerve, which runs down both sides of the neck next to the trachea. The device stimulates the nerve for two minutes by way of a proprietary signal electroCore developed that passes through the skin.

    "That will cause the nerve to fire and in turn create a therapeutic effect very similar to what a drug might elicit for a patient," Amato said.

    [Image credit: electroCore Inc.]

  • Herstal, Belgium-based Cefaly was first to market with a device aimed at preventing migraine pain. FDA cleared the company's transcutaneous electrical nerve stimulation (TENS) device for use prior to the onset of pain back in 2014. The device is designed to send a small electric current to stimulate the trigeminal nerve. This stimulation is intended to reduce the number of migraine headaches.

    More recently, Cefaly began working on a new application for the device, focusing on the chronic migraine population. Jean-Yves Mignolet, R&D manager for Cefaly, explained that the original clearance was based on trials that focused on acute migraine sufferers, people who have between two to eight migraine attacks a month, rather than those suffering from chronic migraines (15 or more headache days per month for at least three months).

    The Cefaly device pictured above consists of a self-adhesive electrode that is placed on the forehead and the device is magnetically connected to this electrode. Precise micro-impulses are then sent through the electrode to the upper branch of the trigeminal nerve to either relieve the headache pain during a migraine attack (acute setting) or to prevent future migraine attacks (prevent setting).

    Last year the company reported data from a study of patients who had an average of 19 migraine days per month. During the study, these patients' migraine days were significantly reduced by 23% after three months of treatment with the Cefaly device. The study also found that the patients' consumption of anti-migraine medication was reduced by 31%.

    A sub-analysis was performed on a group of patients suffering from permanent headache, which is the most difficult category of migraine patients to treat, yet even in this category patients showed significant improvement with a reduction of 36% in oral anti-migraine medication.

    “One of the issues with medication is the more you take, the more you’re at risk for medication overuse, which is also a source of headache,” Mignolet said.

  • FDA just this week granted eNeura's sTMS device clearance for the expanded indication of acute and preventive treatment of migraine in children as young as 12. The device has been cleared for adults since 2017.

    sTMS is a non-invasive prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce a mild electric current that modulates nerve cells in the brain. The technology is believed to interrupt the brain hyperactivity associated with migraine, eNeura said. Treatment with the portable, patient-controlled sTMS device takes just a few seconds, the company noted. Patients place the device at the back of the head and push a button to deliver a focused magnetic pulse to treat a migraine attack or to prevent the onset of a migraine attack.

    “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.,” said David Rosen, MD, president and CEO of eNeura. “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 was supported, in part, by eNeura’s ESPOUSE study, which was conducted in adult patients at eight U.S. headache centers. Following a protocol of daily use, 46% of patients reported at least a 50% reduction in headache attacks. There were no serious adverse events reported during the study.

  • Scottsdale, AZ-based Theranica has filed for FDA clearance of its Nerivio Migra device and the company plans to bring the device to market by the end of this year.

    In November the company 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 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).

    "The study endpoints cover all the main clinical benefits that are really important for patients," said Brian Grosberg, MD, director of the Hartford Healthcare Headache Center in Connecticut, and the lead principal investigator of the study. "Statistical significance was obtained not only at post 2 hours, but also post 48 hours after the treatment, without any consumption of pain killers 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."

  • Another device being studied for migraine patients is the Caloric Vestibular Stimulator. It has an internal computer system and activates stimulation through prongs inserted in the patient’s ear, like headphones. The device is designed to heat and cool the vestibular nerve inside the ear, which is believed to cause changes in the brain that may gradually reduce migraine frequency over three months when used twice a day for 20 minutes at a time. The device is being studied by researchers at the University of Kent.

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