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BrainsWay on Monday announced final results from a pivotal trial of its H4 Deep transcranial magnetic stimulation (Deep TMS) system, demonstrating that the treatment helped significantly more chronic smokers abstain from smoking over a four-week period compared with placebo. Interim CEO David Zacut said the company would meet with the FDA "shortly to discuss our planned regulatory submission and the potential clearance pathway for this important treatment." He also suggested that smoking cessation could turn out to be a "significant market opportunity" for Deep TMS, if approved.
The trial randomised 262 adults suffering from chronic smoking addiction to be treated with either the H4 Deep TMS coil targeting addiction-related brain circuits, or placebo. BrainsWay noted that the participants had a history of smoking on average for over 26 years and multiple failed attempts to quit. The primary endpoint was a comparison between the two groups of the four-week continuous quit rate (CQR). Weekly abstinence was defined as a participant's self-report of no smoking, which was confirmed by urine tests.
Among the 168 participants who completed three weeks of treatment, plus an additional three weeks of follow-up, the CQR was 28.4% for the H4 Deep TMS group versus 11.7% for placebo. BrainsWay said the primary endpoint was defined based on the CQR among participants who received at least one Deep TMS or placebo treatment and had at least one post-baseline assessment, even if not completing the treatment period. Within this cohort of 234 participants, which included drop-outs, the CQR was 19.4% for H4 Deep TMS and 8.7% for placebo.
The company said the study also met a key secondary goal of reduction in the number of cigarettes smoked. The average baseline number of cigarettes smoked per week was 132 for the Deep TMS group and 127 for placebo. Those numbers fell to 38 and 57, respectively, at three weeks, and dropped to 31 and 48 at week six. Overall, the treatment was found to be well-tolerated and no seizures were reported, BrainsWay added.
According to BrainsWay, the system uses technology to "effectively stimulate areas of the brain at a greater depth and breadth than any other commercially available TMS device." The company noted that the H4 helmet used in the study, which is different from its FDA-cleared H1 coil for the treatment of major depressive disorder and H7 coil for obsessive-compulsive disorder, is designed to non-invasively stimulate brain networks known to be associated with addictions via brief electromagnetic pulses.
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