UPDATED April 24, 2019, with comment from NeuroSigma.
NeuroSigma won de novo clearance from the FDA last week to put the first medical device for treating attention-deficit hyperactivity disorder on the U.S. market.
Los Angeles-based NeuroSigma makes the Monarch eTNS system, which is designed to deliver mild electrical signals through a forehead patch to stimulate branches of the trigeminal nerve during sleep. The device won CE Mark approval in the European Union in November 2015 for treating ADHD in in adults and children age 7 and older.
The federal safety watchdog said it based the approval on a 62-patient study that compared four weeks of Monarch eTNS treatment with a sham device, with a primary endpoint of improvement on the ADHD-RS scale. Patients in the treatment arm showed statistically significant improvement compared with the placebo group, the FDA said, with ADHD-RS scores decreasing -31.4% from 34.1 points to 23.4 points; the sham control arm showed a decrease of -18.4%, from 33.7 to 27.5 points.
“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” CDRH neurological & physical medicine devices director Carlos Peña said in prepared remarks. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”
“We are extremely pleased by FDA’s clearance of the Monarch as a monotherapy for pediatric ADHD. We want to thank the FDA team for their efforts during the review process to bring it to a timely and successful completion,” president & CEO Leon Ekchian said in a press release. “We also want to applaud the efforts of the clinical team at UCLA. We look forward to building a commercial organization in the U.S. to offer children, their parents and their physicians a compelling, low-risk, non-drug alternative to current medication treatment options for ADHD.”
“I am excited that we found significant reductions in ADHD symptoms, as well as associated improvements in brain functioning, as a result of TNS therapy,” added principal investigator Dr. James McGough of UCLA’s Neuroscience & Human Behavior Institute. “Treatment was well accepted by patients and families, compliance was high, and the results demonstrated a favorable safety profile for the device. TNS has great potential as an additional option for managing ADHD.”