FDA clears commercialization of first medical device for ADHD treatment

SPRING MONEY, Md., April 19, 2019 / PRNewswire / – The US Food and Drug Administration has authorized the marketing of the first medical device to treat Attention Deficit Hyperactivity Disorder (ADHD). The prescription device, called the external Monarch Trigeminal Nerve Stimulation (eTNS) system, is indicated for patients 7 to 12 years of age who are not currently taking prescription medication for ADHD. FDA.

"This new device provides a safe and non-drug option for the treatment of ADHD in pediatric patients through light nerve stimulation, a first of its kind," said Carlos Peña, Ph.D., director of the Division of Neurological and Neurological Diseases. Physical medicine devices in the center for devices and radiological health of the FDA. "The actions taken today demonstrate 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 needs." specific needs."

ADHD is a common disorder that starts in childhood. Symptoms include difficulty staying focused and alert, difficulty controlling behavior, and a very high level of activity. The diagnosis of ADHD requires a complete badessment by a health professional. For a person to be diagnosed with ADHD, the symptoms of inattention and / or hyperactivity-impulsivity must be chronic or persistent, impair the person's functioning and cause him to fall behind on his normal development for his age.

The Monarch eTNS system is designed to be used at home under the supervision of a caregiver. This device the size of a mobile phone generates a low intensity electrical pulse and connects via a wire to a small patch that adheres to the patient's forehead, just above the eyebrows, and must give the impression of a tingling sensation on the skin. The system provides low-level electrical stimulation to the trigeminal nerve branches, which sends therapeutic signals to the parts of the brain that are thought to be involved in ADHD. Although the exact mechanism of eTNS technology is not yet known, neuroimaging studies have shown that eTNS technology increases activity in brain regions recognized to play an important role in the regulation of attention , emotions and behavior.

The stimulation should feel like a tingling sensation on the skin and the device should be used at home under the supervision of a health care provider during sleep periods. Clinical trials suggest that a response to treatment with eTNS may take up to 4 weeks before becoming evident. Patients should consult their health care provider after four weeks of use to evaluate the effects of treatment.

The effectiveness of the Monarch eTNS system in the treatment of ADHD has been demonstrated in a clinical trial comparing eTNS as a single treatment, or monotherapy, to a placebo device. A total of 62 children with moderate to severe ADHD participated in the trial and used the eTNS treatment every night or a placebo device at home for four weeks. The primary endpoint of the trial was the improvement in the scale of badessment of ADHD administered by a clinician, ADHD-RS. ADHD-RS scales are used to monitor the severity and frequency of ADHD symptoms. A higher score indicates worsening of symptoms. ADHD-RS uses questions about the patient's behavior, for example if he has difficulty paying attention or if he regularly interrupts others. The trial showed that patients using the eTNS device had a statistically significant improvement in their ADHD symptoms compared to the placebo group. By the end of the fourth week, the average ADHD-RS score in the active group had increased from 34.1 points to 23.4 points in the beginning, compared to a decrease from 33.7 to 27.5 points in the placebo group.

The most commonly observed side effects with the use of eTNS are: drowsiness, increased appetite, sleep disturbances, clenching of the teeth, headaches and fatigue. No serious adverse events have been badociated with the use of the device.

The Monarch eTNS System should not be used in children under seven years of age. It should not be used in patients with an active implantable pacemaker or active implantable neurostimulators. Patients equipped with portable devices such as insulin pumps should not use this device. The eTNS system should not be used in the presence of radiofrequency energy such as magnetic resonance imaging (MRI) because it has not been tested on an MRI or mobile phone because the weak Electromagnetic energy levels of the phone can interrupt the treatment. .

The FDA has reviewed the Monarch eTNS system through the pre-market review procedure de novo, a regulatory procedure for devices of a new low-to-moderate risk type. This action creates a new regulatory clbadification, meaning that the following devices of the same type with the same intended use can follow the FDA's 510 (k) pre-market marketing process, under which devices can obtain marketing authorization by demonstrating substantial equivalence with a predicate device.

The FDA has granted marketing authorization for the Monarch eTNS system to NeuroSigma.

The FDA, an agency of the US Department of Health and Human Services, promotes and protects public health, including by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and vaccines. other biological products for human use, and medical devices. The agency is also responsible for the safety of food products, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.

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SOURCE US Food and Drug Administration

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