The Food and Drug Administration (FDA) has cleared BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) system with H4-coil for use as an aid in short-term smoking cessation in adults.
The outpatient procedure provides noninvasive magnetic stimulation to areas of the brain known to be associated with addiction. Approval for use as a smoking cessation therapy was based on data from a multicenter, double-blind, sham controlled trial that evaluated the efficacy and safety of the Deep TMS System with H4-coil in 262 adults. Patients included in the study had a long history of smoking (average of over 26 years) and had multiple failed attempts at quitting.
Patients were randomized to receive either H4 Deep TMS coil or sham daily, 5 days a week for 3 weeks, followed by an additional 3 sessions once a week for 3 weeks. The primary end point was the 4-week continuous quit rate (CQR) at any point from the start of treatment and the follow-up visit 4 months thereafter.
Findings showed a CQR of 17.1% in the active Deep TMS group compared with 7.9% in the placebo group (P =.0238). Among patients with 4 weeks of treatment, diary records, and confirmatory urine samples, the CQR was 28.4% in the Deep TMS group and 11.7% in the placebo group (P =.0063). Additionally, the number of cigarettes smoked per day (secondary end point) was statistically significantly lower in the active Deep TMS arm compared with placebo (P =.0311).
“Based on the compelling data from our large, randomized pivotal study of 262 subjects, we are confident that our Deep TMS technology can play an important role in treating cigarette smokers who seek to quit,” said Christopher von Jako, PhD, President and Chief Executive Officer of BrainsWay. “We look forward to executing a controlled US market release of our newly cleared and proprietary H4 Deep TMS coil for this indication early next year.”
The Company’s Deep TMS platform was previously cleared for the treatment of major depressive disorder and obsessive compulsive disorder.
For more information visit brainsway.com.
- BrainsWay receives FDA clearance for smoking addiction in adults. https://www.globenewswire.com/news-release/2020/08/24/2082476/0/en/BrainsWay-Receives-FDA-Clearance-for-Smoking-Addiction-in-Adults.html. Accessed August 24, 2020.