ADHD Treatment Device Launches - Monthly Prescribing Reference

NeuroSigma’s Monarch outer Trigeminal Nerve Stimulation (eTNS) System is present commercially disposable to dainty attention-deficit/hyperactivity upset (ADHD) successful patients 7 to 12 years of property who are not being treated with ADHD medications.

The instrumentality gained FDA approval successful 2019 based connected information from a placebo-controlled objective proceedings that included 62 children with mean to terrible ADHD. Results showed that attraction with the eTNS instrumentality led to statistically important betterment successful ADHD symptoms, based connected clinician-administered ADHD Rating Scale (ADHD-RS) score, compared with placebo (eTNS group: ADHD-RS people decreased from 34.1 to 23.4 points; placebo group: ADHD-RS people decreased from 33.7 to 27.5 points).

With respect to safety, drowsiness, accrued appetite, slumber disturbance, teeth clenching, headache, and fatigue were the astir communal adverse reactions associated with eTNS therapy.

The Monarch eTNS System is intended for at-home usage nether the supervision of a caregiver. It works by delivering a low-level electrical pulse to the trigeminal nervus done a tiny spot that is placed connected the patient’s forehead. The diligent wears the instrumentality during slumber for astatine slightest 8 hours.

The instrumentality should not beryllium utilized by patients with an progressive implantable pacemaker oregon implantable neurostimulator, oregon successful those with body-worn devices (eg, insulin pumps); it should besides not beryllium utilized successful the beingness of radiofrequency energy, specified arsenic with MRI oregon compartment phones.

To summation entree to the therapy, the Company has besides launched a co-pay programme for commercially insured children. “Given emerging shortages of starring ADHD medications successful the United States, the motorboat of a nondrug alternate to perchance addictive pharmaceutical stimulants is adjacent much imperative successful expanding semipermanent therapeutic options,” said Dr Ian Cook, NeuroSigma’s Chief Medical Officer.

Reference

NeuroSigma Announces Commercial Launch of The Monarch eTNS^® System for the Treatment of Pediatric ADHD astatine 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