The United States’ Food and Drug Administration (FDA) has widened the use of ElectroCore Inc.’s, non-invasive vagus nerve stimulator known as GammaCore, to include preventive applications for cluster headaches in adults.
The device, was previously only approved to treat pain that arise from cluster headaches and migraines. The treatment was self-administered, to give patients electrical stimulations topically in the neck region to activate the vagus nerve and get relief from pain.
Studies Support FDA Decision to Approve
With this new approval, ElectroCore’s device became the first FDA product or therapy that has been approved to prevent cluster headaches. The FDA’s approval was validated by the results from 2 studies that assessed the safety and efficiency of the device in clinical settings and real-world operations.
The first study was the Prevention and Acute Treatment of Chronic Cluster Headache (PREVA) pivotal study, which was an open-label, prospective, controlled, and randomized in nature to accurately assess the device to be suitable for adjunctive therapy.
In the trial, patients who were given standard healthcare care in addition to GammaCore displayed a better reduction in average cluster headaches per week in comparison to the control population that received only standard healthcare.
Driven by massive change from implantable devices to non-invasive devices, vagus nerve stimulators are gradually seeing an increase in the use of transcutaneous vagus nerve stimulators in the coming years, as per a recent study by Future Market Insights on the vagus nerve stimulator market. In addition, rising efforts in R&D towards the integration of new technology eliminate the limitations of implantable vagus nerve stimulators is expected to drive the future developments in this field, says the report.
GammaCore Shows Great Results
In terms of the overall reduction in cluster headaches per patient, per week, it was found that around 40% of patients that got treatment from the stimulator in addition to standard healthcare, resulted in a weekly 50% or greater reduction in comparison to just 8.3% reduction among control patients. Patients treated with the device also displayed a massive 57% reduction in the need to use abortive medicines, in comparison to the control patients, who did not display any noticeable reduction in the use of abortive medicine.
Researchers also found that GammaCore was very safe and was tolerated well by most patients, with the frequency of side effects being similar to that of other alternative treatments. The most commonly reported side effect were headaches, neck pain and dizziness. However, no serious side effects during the study were thought to be related to the device.
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