Neuronetics reported positive topline results from its 169-patient pivotal trial of NeuroStar transcranial magnetic stimulation in adolescents aged 15-21 with treatment-resistant major depressive disorder. The active arm reported a 56% response rate compared with 26% in sham at six weeks.
The data form the basis for the company's submission to the FDA seeking expanded labeling for adolescent depression — an indication currently not approved for any TMS device. An FDA advisory committee voted 9-2 in favor of the expanded indication earlier this month.
Adverse events in the trial were similar to those seen in adult populations: transient scalp discomfort and mild headache. No seizures occurred. Motor threshold determination in adolescents was conducted using a slightly modified protocol to account for skull and brain volume differences.
If the FDA approves the expanded labeling, Neuronetics expects commercial launch within roughly six months of the decision. Insurance coverage for adolescent indications would need to be established with major payers separately.
Source
Reporting based on coverage from Neuronetics. This article is editorial summary intended for general information; it is not medical advice.