Admin_Adham
The FDA has expanded clearance for an accelerated treatment protocol for the noninvasive Deep Transcranial Magnetic Stimulation (Deep TMS, BrainsWay) system for depressive episodes and anxiety symptoms in patients with major depressive disorder (MDD), the development company announced.
The faster protocol is now commercially available in the US, the company reported.
As reported by Medscape Medical News, the system received previous clearance for obsessive-compulsive disorder, smoking addiction, MDD, and comorbid anxiety symptoms in adults with depression.
Although the previous TMS process called for 4 weeks of daily treatments plus follow-up visits, the newly cleared treatment protocol “includes an acute phase of just 6 treatment days,” the company reported in a release.
The expanded clearance was based on results from a recent randomized noninferiority study that the company reported in June. Patients with MDD in the trial (n = 104) received treatment under either the accelerated protocol or the standard protocol.
The accelerated protocol group received five sessions of Deep TMS per day for 6 days over a 14-day period (the acute phase), followed by two sessions per day once weekly for 4 weeks. Each session lasted less than 10 minutes.
The standard group received five sessions per day for 4 weeks (acute phase), followed by two sessions per day once weekly for 2 weeks. Each of its sessions lasted 20 minutes.
Results showed adjusted Hamilton Depression Rating Scale depression score reductions of 19.1 points in the accelerated TMS group compared to 19.8 points in the standard group. In addition, the response rate was 87.8% vs 87.5%; the remission rate was 78% vs 87.5%; and median time to remission was 21 days vs 28 days.
In the statement, the company will provide training to healthcare providers and will be actively seeking reimbursement updates for the accelerated protocol, noting that the current reimbursement for Deep TMS therapy only allows for up to two treatments per day.
