NeuroSigma, a Los Angeles-based bioelectronics company focused on developing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders today announced a partnership with Quick Care Pharmacy, a California-based specialty pharmacy, for sales and distribution of its Monarch eTNS System (Monarch) for the treatment of pediatric ADHD in the United States.
“NeuroSigma’s Early Access program for the Monarch commenced in August, and we have been very pleased with the results. Our partnership with Quick Care will allow us to expand the Early Access Program to all 50 states and serve a wider physician and patient base,” said Leon Ekchian, Ph.D., NeuroSigma’s President and CEO.
On April 19, 2019, the Monarch received marketing clearance from FDA via the de novo pathway, which is typically used for clearance of novel medical devices that are deemed low- to moderate- risk. The Monarch is the first-ever medical device to receive FDA clearance for treating ADHD. Results from the double-blind pivotal trial of the Monarch for treating pediatric ADHD were published in the April 2019 issue of the Journal of the American Academy of Child and Adolescent Psychiatry. The trial’s primary endpoint was the ADHD-RS-IV scale, a scale for assessing ADHD severity that is commonly used in clinical trials of ADHD therapies. After 4 weeks, children randomized to the treatment group showed significant improvements on the ADHD-RS-IV scale as compared to the control group (p = 0.005). The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events were associated with use of the device.
“The Monarch represents a new treatment paradigm for pediatric ADHD,” said Rohit Sheta, President and CEO of Quick Care. “We look forward to working with NeuroSigma on early commercialization of this exciting product. Quick Care’s expertise will help NeuroSigma quickly scale to meet demand for the Monarch eTNS System throughout the United States,” added Sheta.
Source: Company Press Release
