FDA approves transcranial magnetic stimulation system for patients with anxious depression

The FDA has approved Neuronetics’ NeuroStar Advanced Therapy for Mental Health, a transcranial magnetic stimulation system for treatment of anxiety symptoms in adults with major depressive disorder, the company announced in a press release.

In May, the FDA approved the transcranial magnetic stimulation (TMS) system as an adjunct therapy for adults with obsessive compulsive disorder. The non-drug, noninvasive treatment is the first FDA-approved TMS system pioneered for depression, according to the company.

Cory Anderson

“We’re thrilled to receive FDA clearance to use NeuroStar Advanced Therapy to treat anxious depression,” Cory Anderson, vice president of research, development and clinical at Neuronetics, told Healio. “With the FDA clearance for OCD received in May and now the anxious depression indication, we’re making excellent strides towards helping more people find relief from their mental health conditions.”

The FDA reviewed the company’s use of real-world data analyzed by NeuroStar’s TrakStar platform — which contains data from patients treated with the TMS system at more than 1,000 centers — to grant clearance for the new indication.

According to the release, TrakStar results from 664 patients with anxious depression demonstrated that 65.5% achieved a clinically meaningful response, which exceeded the pre-established overall study success criteria of a minimum of 50% response rate.

“There are millions of people suffering from major depressive disorder who also have anxiety symptoms and, significantly, we were able to leverage outcomes from hundreds of patients in our proprietary TrakStar database of real-world outcomes in the FDA review,” Anderson said. “NeuroStar providers can now let anxious depression patients know that NeuroStar TMS can be a potential benefit for both their MDD and anxiety symptoms.”