FDA News

FDA permits marketing of brain stimulation system for OCD

The FDA has permitted Brainways Ltd. to market the Brainsway Deep Transcranial Magnetic Stimulation System for the treatment of obsessive compulsive disorder, according to a press release.

“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” Carlos Peña, PhD, MS, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in the press release. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”

In 2008, the FDA permitted marketing of transcranial magnetic stimulation (TMS) as a treatment for major depression and expanded its use for treating pain related to certain migraine headaches in 2013, according to the release.

The FDA examined data from a randomized, multicenter study where 49 patients received treatment with the Brainsway device and 51 received treatment with a sham device to determine the reduction in patients’ Yale-Brown Obsessive-Compulsive Scale score, according to the release. Participants already receiving OCD treatments maintained their current dosages throughout the study.

The study found that 38% of patients responded to the Brainsway device, demonstrating a greater than 30% drop in obsessive-compulsive score, while 11% of patients responded to the sham device.

Participants reported no serious adverse reactions related to the Brainsway device, according to the release. The most frequent adverse reaction reported by patients in the Brainsway treatment group and the sham treatment group was headache (37.5% vs. 35.3%). Other adverse reactions, which were mild or moderate and resolved shortly after treatment, included application site discomfort, jaw pain, facial pain, muscle pain, spasm or twitching and neck pain. Patients with a history of seizures should discuss their history with their health care provider before receiving the Brainsway device, the release noted.

Disclosure: Peña is an employee of the FDA.

The FDA has permitted Brainways Ltd. to market the Brainsway Deep Transcranial Magnetic Stimulation System for the treatment of obsessive compulsive disorder, according to a press release.

“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” Carlos Peña, PhD, MS, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in the press release. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”

In 2008, the FDA permitted marketing of transcranial magnetic stimulation (TMS) as a treatment for major depression and expanded its use for treating pain related to certain migraine headaches in 2013, according to the release.

The FDA examined data from a randomized, multicenter study where 49 patients received treatment with the Brainsway device and 51 received treatment with a sham device to determine the reduction in patients’ Yale-Brown Obsessive-Compulsive Scale score, according to the release. Participants already receiving OCD treatments maintained their current dosages throughout the study.

The study found that 38% of patients responded to the Brainsway device, demonstrating a greater than 30% drop in obsessive-compulsive score, while 11% of patients responded to the sham device.

Participants reported no serious adverse reactions related to the Brainsway device, according to the release. The most frequent adverse reaction reported by patients in the Brainsway treatment group and the sham treatment group was headache (37.5% vs. 35.3%). Other adverse reactions, which were mild or moderate and resolved shortly after treatment, included application site discomfort, jaw pain, facial pain, muscle pain, spasm or twitching and neck pain. Patients with a history of seizures should discuss their history with their health care provider before receiving the Brainsway device, the release noted.

Disclosure: Peña is an employee of the FDA.