#1. First FDA-Approved Device for ADHD

Could mild electrical pulses, delivered to a major nerve of the head and brain, ease ADHD symptoms in kids?

In 2019, a small University of California Los Angeles study of 62 girls and boys, ages 8 to 12, with moderate to severe ADHD found that 52% of those treated with the Monarch external Trigeminal Nerve Stimulation (eTNS) System for four weeks had significant reductions in inattentiveness, hyperactivity, and impulsiveness. In comparison, just 14% in a control group saw improvements. The study was published in the April 2019 issue of the Journal of the American Academy of Child & Adolescent Psychiatry.

In the spring of 2019, the US Food and Drug Administration approved the marketing of the prescription-only device for children ages 7 to 12 with ADHD who are not taking medications for the condition. 2 It was the agency’s first OK of a non-drug device for the treatment of ADHD.

How It Works

Kids wear the eTNS unit at night, clipped to their pajamas. A wire sends low-level electrical pulses to an adhesive patch placed on the child’s forehead, just above their eyebrows. They may feel a slight tingling sensation on their skin.

“Studies suggest that eTNS stimulates the cranial nerves in the forehead, which in turn stimulate various brain areas implicated in ADHD such as the anterior cingulate, insula, and frontal lobes,” explains eTNS researcher Sandra K. Loo, PhD, Director of Pediatric Neuropsychology at UCLA’s Semel Institute for Neuroscience. “The brain areas that are indirectly stimulated by eTNS are thought to improve certain cognitive abilities called executive functions (such as inhibitory control and working memory), which are impaired in about 50% of individuals with ADHD. Both executive functions and ADHD symptoms seem to improve together with eTNS treatment.”

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Does Insurance Cover It?

The $980 system is approved only for kids ages 7 to 12 who don’t take ADHD medications; it hasn’t been extensively studied or approved yet for teens and adults.

While new products approved for the treatment of ADHD are not typically, or immediately, reimbursed by insurance the pharmacy that handles eTNS System prescriptions will work with families to try and obtain coverage through their insurance company’s prior authorization process. Visit the device manufacturer’s website to learn more.

How Does eTNS Compare to Other Treatments for ADHD?

While eTNS hasn’t been compared head-to-head with other ADHD treatments, Loo notes that the improvements are on par with those of the widely-used, non-stimulant ADHD medications atomoxetine and guanfacine.

But stimulant ADHD drugs are generally regarded as more effective. The eTNS effects are bigger than those found in other studies for non-drug therapies like neurofeedback, child and parent training, omega-3 fatty acids, and cognitive therapy.

Side effects were mild, including an increase in appetite and weight, higher pulse, fatigue, and headache. But none of the participants in the 2019 study had serious reactions or stopped using the device. Loo and a team at UCLA continued to study eTNS for ADHD, finding that kids who responded best tended to have lower scores in spelling and math and more problems with working memory than non-responders, according to a study published in October 2020 in the Journal of the American Academy of Child & Adolescent Psychiatry.

While more research is needed, she notes that it may be “one of the better non-medication treatment options for ADHD” for kids who don’t respond to medication or have serious side effects.

#2. Video Games: Digital Therapy for ADHD

EndeavorRx, a digital game therapy for ADHD, made medical history in June 2020 when it won FDA approval.

The video game is not only the first prescription-only game treatment for ADHD, it’s the first gaming therapy of any kind to gain an FDA OK. Aimed at kids ages 8-12 with the inattentive type of ADHD (formerly known as ADD) which does not include symptoms of hyperactivity and impulsivity, the fast-paced game launches players down fiery rivers, through icy winter landscapes, and along a variety of ever-changing environments, steering around obstacles and collecting targets with the aid of friendly aliens in flying saucers.

According to developer Akili Interactive, the experience uses brain systems important for attention. It targets “cognitive interference”—when two or more tasks compete for our attention—helping players practice the job of managing distractions and staying focused. Adaptive algorithms built into the game software adjust the difficulty level for each player so that kids are constantly challenged.

It seems to work. In a February 2020 study in the journal Lancet Digital Health, 348 kids with ADHD played EndeavorRx or a digital word game for 25 minutes a day, five days a week. The EndeavorRx group showed significantly greater improvements in attention than the control group. In addition, 48% of parents reported that kids who played EndeavorRx improved their day-to-day functioning and 56% saw improvements in their child’s attention.3

Does Insurance Cover It?

The game is intended to be used along with other ADHD therapies including medication, educational programs, and other therapies recommended by a child’s healthcare practitioner. It is available with a doctor’s prescription through Akili, with an initial three-month access period costing about $450.

EndeavorRx is currently NOT covered by health insurance, but the developer Akili says it has an assistance program that lowers the price for 3 months of access for some families. Find out more in the FAQ section of the company’s website.

How It Works

Akili recommends kids use the game 25 minutes a day, five days a week, to be evaluated by their doctor after three months to determine if treatment should continue. Parents get access to a mobile app to help them track their child’s use of the game, symptom and behavior changes, and to provide support. Families can view a brief demo at https://apps.apple.com/us/app/endeavor-adhd/id1458156758.

“It made a lot of sense to me, to leverage what kids are doing in video gaming to help them build skills such as attention,” says psychologist Randy Kulman, PhD, president of Learning Works for Kids and an expert in the use of video games to bolster focus, executive function and other skills in people with ADHD.

“You can’t learn unless you pay attention, so you have to start with that. Here we have a wonderful tool that captures attention. The question with all online training, including gaming, is whether the skills are transferable—can you use them in the real world? Akili’s research suggests they are.”

#3. Experimental Non-Stimulant Drug Improves ADHD Symptoms in Children and Adults

The experimental drug SPN-812 (viloxazine extended-release) made headlines during the summer of 2020 when it reduced hyperactivity/impulsivity and inattention in a study of 460 children, ages 6-11, with ADHD. Functioning in school and with friends and family improved, too. More recently, in December 2020, the drug’s manufacturer announced positive results from a Phase III study of the same drug in adults as well.4

Published online in the journal Clinical Therapeutics on July 25, 2020, the study of children was conducted by the drug developer Supernus Pharmaceuticals, Inc. (located in Rockville, Maryland) and researchers from SUNY Upstate Medical University in New York State. “SPN-812 significantly reduced ADHD symptoms in children and was well tolerated,” noted lead researcher Azmi Nasser, PhD, and his research team in the study. “SPN-812 may prove to be an effective treatment for children with ADHD.” 5

How It Works

The non-stimulant drug increases levels of serotonin, norepinephrine, and dopamine—brain chemicals that may be involved with ADHD.3 It “has the potential of becoming the first novel treatment to be introduced in the ADHD market in more than a decade,” Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals, said in a statement.

“For children diagnosed with ADHD, SPN-812 has the potential to be a much-needed addition to the current armamentarium of ADHD therapies,” note the authors of another 2020 study, published in the Journal of Attention Disorders, that also found improvements in hyperactivity/impulsivity in kids who took SPN-812.

Teens with ADHD saw improvements with the drug, too, according to a 2019 study presented at Psych Congress, a large, independent US mental health conference. And studies testing the safety and effectiveness of the drug for adults with ADHD are also in the works.6,7

Viloxazine itself is not a new drug. It was sold in Europe and the UK to treat depression starting in the 1970s but withdrawn from the market in the early 2000s due to competition from other antidepressants, according to the National Institutes of Health. Now, it could become a new ADHD treatment alternative—something people with ADHD and their families are looking for.

According to SPN-812 researchers writing in the Journal of Attention Disorders in 2020, about 10-30% of kids and teens with ADHD don’t respond “optimally” to the widely-used stimulant ADHD drugs methylphenidate and amphetamine or can’t tolerate their side effects. Still, others find that non-stimulant ADHD drug alternatives such as atomoxetine, guanfacine, and clonidine don’t work well or their side effects like low appetite and sleepiness are too severe. “There is a need for alternative non-stimulant options,” they note.

How It Was Studied In Adults with ADHD

The P306 Study, a separate study in adults, was a randomized, double-blind, placebo controlled, multicenter, parallel-group clinical trial of 374 adult patients diagnosed with ADHD.

The treatment was administered orally once a day over six weeks and studied at an initial dose of 200 mg and titrated up to 600 mg SPN-812, or the placebo. Study results showed statistically significant improvement in hyperactivity, impulsivity, and inattention. Side effects were insomnia, fatigue, decreased appetite, nausea, headache, and dry mouth.

SPN-812 hit a speed bump in November 2020, when the FDA decided that Supernus’ application for the drug’s use in kids was “not ready for approval in its present form”.  According to Supernus, the issue was the company’s decision to move their in-house lab. “Importantly, no clinical safety or efficacy issues were identified during the review,” the company notes.

Supernus is scheduled to meet with the FDA to discuss the issue later this month (January). Assuming the FDA gives the go ahead for the drug’s use in children 17 and under, the company plans to submit a New Drug Application (NDA) to the agency for SPN-812 for adults in the second half of 2021.

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Last Updated: Jan 7, 2021