FDA Clearance for Neuronetics’ Adjunct Treatment for Depression in Adolescents

 Medical technology company, Neuronetics, Inc. (Nasdaq: STIM), has received clearance from the FDA for its NeuroStar Advanced Therapy for use as an adjunct for the treatment of major depressive disorder (MDD) in adolescent patients. This is the fourth FDA-cleared indication for NeuroStar.

“The current treatment options available for adolescents are extremely limited, compared to those available for adults,” said Dr. Kenneth Pages, Medical Director of 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.”

NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment to be cleared by the FDA for use in this age group.

The FDA’s decision is based on an analysis of real-world data collected through NeuroStar’s proprietary TrakStar® platform. This platform provided crucial insights into the treatment’s effectiveness and safety profile in adolescents, showing that among the 1,169 adolescents in the data analysis, 78% achieved clinically meaningful improvement in their depression severity.

Adolescent depression is a complex and challenging mental health condition that affects an estimated 4.3 million young people in the US. 

About Neuronetics

Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health. NeuroStar is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication hasn’t helped. NeuroStar is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from MDD and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. It is also FDA-cleared as an adjunct for adults with obsessive-compulsive disorder and for adolescent patients aged 15-21 with MDD.   NeuroStar Advanced Therapy is the leading TMS treatment for MDD in adults with over 6.1 million treatments delivered. NeuroStar is backed by the largest clinical data set of any TMS system for depression, including the world’s largest depression outcomes registry. Neuronetics is committed to transforming lives by offering an exceptional treatment that produces extraordinary results. For safety and prescribing information, visit www.neurostar.com.

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FDA Clearance for Neuronetics’ Adjunct Treatment for Depression in Adolescents

Catie Corcoran

Biotech Editor