The FDA cleared a new indication for Neuronetics’ (NASDAQ:STIM) transcranial magnetic stimulation (TMS) system – NeuroStar Advanced Therapy for Mental Health – to treat anxiety symptoms for adult patients who suffer from major depressive disorder (MDD), also known as anxious depression.
“Many people suffering from MDD also experience anxiety symptoms, and these patients with anxious depression are more likely to be severely depressed and to have more thoughts of suicide,” Keith Sullivan, president and CEO of Neuronetics, said in a statement.
“This new indication means providers can now describe to MDD patients the benefit of NeuroStar for improving their anxiety symptoms,” he added.
The FDA accepted Neuronetics’ use of real-world data analyzed from NeuroStar’s proprietary TrakStar platform in granting clearance for MDD. The TrakStar database contains digital data from patients treated with NeuroStar at more than 1,000 centers. Real-world data from TrakStar provides a large sample from a diverse patient group being treated in a clinical practice setting.
The TrakStar results from 664 anxious depression patients demonstrated that 65.5% achieved a clinically meaningful response, which exceeded the pre-established overall study success criteria of a minimum 50% response rate.
NeuroStar is a leader in patient-focused TMS therapy having treated more than 134,000 patients who completed more than 4.8 million treatment sessions. In May 2022, the FDA cleared NeuroStar to treat obsessive compulsive disorder.
Melissa Fickey, M.D., founder of Embracing Life Wellness Center, said a clinical presentation of anxiety symptoms in patients with MDD is typically more complex to successfully treat with currently available medications.
“NeuroStar has presented a robust data set from more than 1,300 patients showing safety and efficacy in relieving both depression and anxiety symptoms in patients with anxious depression,” Dr. Fickey added.