FDA Approves TMS Device for Major Depressive Disorder in Adolescents
The US Food and Drug Administration (FDA) approved on Wednesday the Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices for the adjunctive treatment of major depressive disorder (MDD) in adolescents, announced device manufacturer neurocare group AG.
MDD affects an estimated 5 million teens in the US every year, but treatment options remain limited. Only 2 oral antidepressants—escitalopram and fluoxetine—are currently approved for MDD treatment in this age. Both carry a black box warning. Further, the efficacy rates of the medications are only 35% for achievement of remission, with many patients discontinuing them due to side effects or inefficacy.
“TMS offers a safe, non-invasive, and drug-free alternative, with no black box warning and no medication-related side effects,” said neurocare in a press release. “Clinical studies show that approximately 60% of patients achieve remission with TMS, making it a promising new treatment option for adolescents who have not found success with other treatments.”
The Apollo TMS Therapy device has received 2 other FDA clearances: one for MDD treatment in adult patients who had an inadequate response to oral antidepressants, and the other for adjunctive treatment of obsessive-compulsive disorder (OCD) in adult patients who did not respond to traditional therapies.
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