NeuroStar Advanced Therapy receives FDA clearance for adolescents with depression

NeuroStar Advanced Therapy receives FDA clearance for adolescents with depression © Andrey - stock.adobe.com

Neuronetics has announced the FDA has cleared NeuroStar Advanced Therapy as an adjunct treatment for major depression disorder (MDD) in adolescent patients 15-21 years.

This decision makes NeuroStar Advanced Therapy the first and only transcranial magnetic stimulation (TMS) therapy cleared by the FDA as an adjunct treatment for patients 15 years and up with depression.

Depression is one of the most complex and challenging mental health conditions affecting adolescents, with approximately 4.3 million young individuals (ages 15-21 years) in the United States reporting being affected by depression, according to a company press release announcing the FDA clearance. Additionally, depression can affect adolescents in a variety of ways, such as disrupting academic performance, emotional well-being, and relationships.

"The prevalence of depression in adolescents and young adults has been accelerating since the COVID-19 pandemic. The current treatment options available for adolescents are extremely limited, compared to those available for adults," said Kenneth P. Pages, MD, medical director, TMS of South Tampa. "NeuroStar’s TMS therapy now offers a promising first-line treatment for adolescents, backed by real-world data and impressive response rates consistent with response rates for adults. This advancement has the potential to set a new treatment paradigm for how we address depression in our youth."

The FDA’s decision was based off study data which examined the therapy’s efficacy and safety in 1,169 adolescents, with 78% of patients achieving clinically meaning improvement in depression severity, according to the company.

According to the company, “The FDA reviewed the comprehensive data set from TrakStar, along with clinical data from the published literature, and concluded that NeuroStar TMS was substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone in this population.”

Reference:

NeuroStar Advanced Therapy Receives FDA Clearance as a First-Line Add-On Treatment for Adolescents with Depression. Neuronetics. March 25, 2024. Accessed March 28, 2024. https://ir.neuronetics.com/news-releases/news-release-details/neurostarr-advanced-therapy-receives-fda-clearance-first-line