NeuroSigma Announces Agreement with Teijin for ADHD Device
Teijin Ltd., the Japanese pharmaceutical and medical device manufacturer, and NeuroSigma, Inc., the Los Angeles, CA manufacturer of trigeminal nerve stimulation systems, announced entering into a partnership based on an exclusive license agreement that grants Teijin Pharma exclusive rights to NeuroSigma’s TNS patent rights in Japan related to ADHD and to market the Monarch eTNS System for the noninvasive treatment of ADHD in Japan.
As part of the agreement, Teijin will seek regulatory approval in Japan for the therapy. The Monarch was the first non-drug treatment cleared by the FDA for the treatment of pediatric ADHD. In the U.S., the prescription-only Monarch device is indicated for treatment of pediatric ADHD as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is intended to be used in the home under the supervision of a caregiver during periods of sleep. The most common side effects observed with Monarch use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events are associated with use of the device.
“NeuroSigma’s corporate strategy is to focus on the U.S. market while partnering with leading life sciences companies outside the U.S.,” said Leon Ekchian, CEO of NeuroSigma.