FDA approves BrainsWay’s smoking cessation device.
The US Food and Drug Administration (FDA) has granted marketing approval for the BrainsWay deep transcranial magnetic stimulation (deep TMS) system designed to help with smoking cessation. This is the company’s third FDA-approved indication for its deep TMS system and the first FDA approval for any TMS device for addiction. It had already received the federal agency’s approval for treatment of obsessive-compulsive disorder and major depressive disorder. The BrainsWay deep TMS system with H4-coil targets addiction-oriented brain circuits.
In clinical trials, active and placebo smoking cessation treatments were performed on 262 adult participants who smoked for more than 26 years daily five days weekly for a duration of three weeks, followed by an additional three sessions once weekly for three weeks. The four-week continuous quit rate (CQR, the primary endpoint) was higher in the active deep TMS group than in the placebo group. The average number of cigarettes smoked per day, based on daily records, was statistically significantly lower in the active group compared to the placebo group. The most common adverse event was headache and no patients suffered a withdrawal seizure.
“The data from this large randomized pivotal study indicate that our Deep TMS can play an important role in treating cigarette smokers who seek to quit,” said David Zacut, Chairman and Interim Chief Executive Officer of BrainsWay. “We are very encouraged by these clinical results and look forward to meeting with the U.S. Food and Drug Administration (FDA) shortly to discuss our planned regulatory submission and the potential clearance pathway for this important treatment. If cleared, we believe that smoking cessation could be a significant market opportunity for Deep TMS and BrainsWay. Moreover, the success demonstrated in this study in treating patients addicted to cigarettes strengthens our optimism with respect to the potential for the use of our platform technology to treat other addictions as well.”
“Tobacco smoking is one of the primary causes of preventable death and also leads to other serious conditions, such as cancer and heart disease,” said Dr. Aron Tendler, Chief Medical Officer at BrainsWay. “While there are several treatment options currently available, the development of other therapies is critical to increasing the continuous quit rate among smokers. Findings from our multicenter study indicate that Deep TMS could potentially serve as a treatment option for inducing smoking cessation. BrainsWay is proud to be at the forefront of non-invasive brain stimulation for addiction and we are focused on working to make Deep TMS available to patients attempting to successfully quit smoking as expeditiously as possible.”
“This FDA clearance represents a significant milestone for BrainsWay and our deep TMS platform technology,” Christopher von Jako, PhD, president and CEO of the company, said. “While other therapies are currently available, a substantial medical need continues to exist for treatments that can increase the continuous quit rate among smokers. 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.”
The company anticipates adapting a controlled U.S. release in early 2021.