NeuroSigma’s Monarch external Trigeminal Nerve Stimulation (eTNS) System is now commercially available to treat attention-deficit/hyperactivity disorder (ADHD) in patients 7 to 12 years of age who are not being treated with ADHD medications.
The device gained FDA approval in 2019 based on data from a placebo-controlled clinical trial that included 62 children with moderate to severe ADHD. Results showed that treatment with the eTNS device led to statistically significant improvement in ADHD symptoms, based on clinician-administered ADHD Rating Scale (ADHD-RS) score, compared with placebo (eTNS group: ADHD-RS score decreased from 34.1 to 23.4 points; placebo group: ADHD-RS score decreased from 33.7 to 27.5 points).
With regard to safety, drowsiness, increased appetite, sleep disturbance, teeth clenching, headache, and fatigue were the most common adverse reactions associated with eTNS therapy.
The Monarch eTNS System is intended for at-home use under the supervision of a caregiver. It works by delivering a low-level electrical pulse to the trigeminal nerve through a small patch that is placed on the patient’s forehead. The patient wears the device during sleep for at least 8 hours.
The device should not be used by patients with an active implantable pacemaker or implantable neurostimulator, or in those with body-worn devices (eg, insulin pumps); it should also not be used in the presence of radiofrequency energy, such as with MRI or cell phones.
To increase access to the therapy, the Company has also launched a co-pay program for commercially insured children. “Given emerging shortages of leading ADHD medications in the United States, the launch of a nondrug alternative to potentially addictive pharmaceutical stimulants is even more imperative in expanding long-term therapeutic options,” said Dr Ian Cook, NeuroSigma’s Chief Medical Officer.
NeuroSigma Announces Commercial Launch of The Monarch eTNS® System for the Treatment of Pediatric ADHD at Annual Meeting of the American Academy of Child and Adolescent Psychiatry. News release. NeuroSigma, Inc. Accessed October 17, 2022. https://www.globenewswire.com/news-release/2022/10/17/2535585/0/en/NeuroSigma-Announces-Commercial-Launch-of-The-Monarch-eTNS-System-for-the-Treatment-of-Pediatric-ADHD-at-Annual-Meeting-of-the-American-Academy-of-Child-and-Adolescent-Psychiatry.html