FDA OKs Neuronetics’ Neurostimulation for Adolescents with Depression

Neuronetics has earned U.S. Food and Drug Administration (FDA) clearance for its NeuroStar advanced therapy’s use as an adjunct to treat major depressive disorder (MDD) in adolescent patients aged 15-21.
 
According to the company, NeuroStar is the first, only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age range. It is the fourth FDA-cleared indication for NeuroStar, the next most recent being the NeuroSite coil placement accessory earlier this month.
 
The FDA nod was based in part on real-world data collected from NeuroStar’s TrakStar platform, which offered insights into the treatment’s effectiveness and safety in adolescents. 78% of the 1,169 adolescents in the data analysis reached clinically meaningful improvement in their depression severity, according to the data.
 
The FDA concluded NeuroStar TMS was substantially equivalent when used as an adjunct to antidepressant therapy, over antidepressants alone in this population, based on TrakStar’s data set and data from the published literature.
 
Dr. Kenneth Pages, Medical Director of TMS of South Tampa said depression’s prevalence has grown since the COVID-19 pandemic, and current treatment options for adolescents are very limited compared to 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,” Dr. Pages told the press. “This advancement has the potential to set a new treatment paradigm for how we address depression in our youth.”
 
Neuronetics said NeuroStar is using the versatility of its coil design for providers to address adolescents’ treatment needs for MDD symptoms immediately, without needing further hardware upgrades or purchases.
 
“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 Neuronetics. “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%.”