FDA Clears NeuroStar TMS for Treatment of MDD in Adolescents

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NeuroStar Advanced Therapy has received clearance from the US Food and Drug Administration (FDA) as an adjunct in the treatment of major depressive disorder (MDD) in adolescent patients aged 15 to 21 years.

This clearance marks NeuroStar as the first and only transcranial magnetic stimulation (TMS) treatment that is FDA-cleared for this age group. MDD in adolescent patients is also the fourth FDA-cleared indication for NeuroStar,¹ along with treatment of MDD in adults, treatment of obsessive-compulsive disorder in adults, and anxiety symptoms in adults with MDD.²

“The prevalence of depression in adolescents and young adults has been accelerating since the COVID-19 pandemic,” said Kenneth Pages, MD, medical director of TMS of South Tampa, in a press release.

“The current treatment options available for adolescents are extremely limited, compared to those available for adults. 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 to grant clearance for this indication is informed by an analysis of real-world data collected through NeuroStar’s proprietary TrakStar® platform. Among the 1169 adolescents analyzed, 78% showed clinically meaningful improvement in depression severity. The FDA reviewed this data set alongside clinical literature and concluded that NeuroStar TMS, when used as an adjunct to antidepressant therapy, is substantially equivalent in terms of safety and effectiveness compared to antidepressant therapy alone in this population.¹

The coil design versatility of NeuroStar also allows providers to address the immediate treatment needs of adolescents with MDD symptoms without requiring additional hardware upgrades or purchases.¹ This feature gives adolescent patients and their families a new option when weighing alternative treatments for depression.³ Access to effective treatment for MDD is important for all patient populations, as MDD is the fourth leading cause of disease burden globally.⁴

“Receiving FDA clearance to treat the adolescent segment aged 15 and up is a treatment solution that is long overdue in the mental health industry,” said Keith J. Sullivan, president and CEO of NeuroStar developer Neuronetics Inc, in a press release.

“We are excited to offer NeuroStar TMS therapy as a new option for young people and for their concerned parents who have struggled to find a treatment they can be confident in. As a company, we will be focused on driving even more awareness and education about NeuroStar given that this new clearance grows our total addressable market in MDD by 35%.”

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of psychiatric disorders at psychiatrictimes.com.

Note: This article was prepared with the assistance of ChatGPT.

References

1. NeuroStar® advanced therapy receives FDA clearance as a first-line add-on treatment for adolescents with depression. GlobeNewswire. News release. March 25, 2024. Accessed March 26, 2024. https://www.globenewswire.com/en/news-release/2024/03/25/2851611/0/en/NeuroStar-Advanced-Therapy-Receives-FDA-Clearance-as-a-First-Line-Add-On-Treatment-for-Adolescents-with-Depression.html

2. Downey Jr K. FDA approves transcranial magnetic stimulation system for patients with anxious depression. Healio. July 20, 2022. Accessed March 26, 2024. https://www.healio.com/news/neurology/20220720/fda-approves-transcranial-magnetic-stimulation-system-for-patients-with-anxious-depression

3. FDA clears NeuroStar TMS for adolescent depression treatment. Investing.com. March 25, 2024. Accessed March 26, 2024. https://www.investing.com/news/stock-market-news/fda-clears-neurostar-tms-for-adolescent-depression-treatment-93CH-3351559

4. Miller B. Meta-analysis of adjunctive TMS in treatment-resistant major depression. Psychiatric Times. September 12, 2023. Accessed March 26, 2024. https://www.psychiatrictimes.com/view/meta-analysis-of-adjunctive-tms-in-treatment-resistant-major-depression