electroCore, a company out of Basking Ridge, New Jersey, received the green light from the FDA to market its gammaCore non-invasive vagus nerve stimulator for treating acute pain resulting from episodic cluster headaches in adult patients. The device is used to deliver electric current through the skin to the vagus nerve by placing the gammaCore’s electrodes on the side of the neck and running its therapy routine.
It can be used just about anywhere and at any time when a painful cluster headache sets in. If effective for individual patients, it can be a major benefit for many who are often treated with a series of drugs that often don’t work and have unpleasant side effects. The gammaCore can be used as frequently as desired and doesn’t have any known serious side effects.
Some details about the study that led to this regulatory decision, according to electroCore:
The FDA release of gammaCore is based on subgroup analyses from two trials in the ACT (Non–Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache) clinical trial program evaluating the safety and efficacy of gammaCore for the acute treatment of episodic cluster headache. Both trials (ACT1 and ACT2) were prospective, double-blind, placebo-controlled, randomized studies evaluating the use of gammaCore versus placebo. Results from ACT1, evaluating 85 patients with episodic cluster headache, found that 34.2% of patients experienced a reduction in pain from episodic cluster headache (defined as the percentage of patients who reported mild or no pain 15 minutes after treatment initiation with gammaCore for the first treated cluster headache attack in the study; use of rescue medication within 60 minutes was considered a treatment failure) compared to 10.6% in patients treated with placebo (p=0.008).Results from ACT2, evaluating 182 attacks in 27 patients with episodic cluster headache, also found that a significantly higher percentage of attacks were pain-free (defined as pain-free at 15 minutes after the onset of pain from cluster headache with no use of rescue medication through the 30-minute treatment period) in patients treated with gammaCore (47.5%) versus placebo (6.2%; p=0.003). In both trials, gammaCore was found to be safe and well-tolerated, with the majority of adverse events (AEs) being mild and transient and occurring during the time of active treatment.
Product page: gammaCore…
Flashback: Vagus Nerve Stimulation for the Masses: Interview with electroCore CEO J.P. Errico…
Via: electroCore…