The US Food and Drug Administration (FDA) has expanded indication for the noninvasive BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMSTM) System to include treatment of comorbid anxiety symptoms in adult patients with depression, the company has announced.
In today's announcement, BrainsWay reported that it has also received 510(k) clearance from the FDA to market its TMS system for the reduction of anxious depression symptoms.
"This clearance is confirmation of what many have believed anecdotally for years — that Deep TMS is a unique form of therapy that can address comorbid anxiety symptoms using the same depression treatment protocol," Aron Tendler, MD, chief medical officer at BrainsWay, said in a press release.
"Consistent, Robust" Effect
Before receiving approval, the company submitted data on 573 patients who underwent this treatment while participating in 11 studies, which included both randomized controlled trials and open-label studies.
"The data demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering from major depressive disorder [MDD]," the company said in its release.
Data from three of the randomized trials showed an effect size of 0.3 when compared with a sham device and an effect size of 0.9 when compared with medication. The overall, weighted, pooled effect size was 0.55.
The company noted that in more than 70 published studies with about 16,000 total participants, effect sizes have ranged from 0.2 - 0.37 for drug-based anxiety treatments.
"The expanded FDA labeling now allows BrainsWay to market its Deep TMS System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from [MDD] and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode," the company said.
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Cite this: FDA OKs Stimulation Device for Anxiety in Depression - Medscape - Aug 18, 2021.