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What treatments were recently approved by the US Food and Drug Administration for pediatric patients with ADHD?
FROM THE REACH INSTITUTE
Treatments recently approved by the US Food and Drug Administration (FDA) for pediatric patients with attention-deficit/hyperactivity disorder (ADHD) include 2 medications that address some of the common issues associated with standard stimulant treatments. Another development is use of devices to manage ADHD symptoms (Table).
Methylphenidate hydrochloride (Jornay PM), a delayed-release/extended-release methylphenidate, was approved by the FDA in 2018 and became commercially available in 2019. It differs from the other methylphenidate-based stimulants in that it is administered before bedtime—between 6:30 pm and 9:30 pm—to take effect in the morning when the child rises.
This delayed action addresses a common problem many families face when stimulants are administered upon rising: Patients are focused and ready to work by the time school starts, but getting children to school is a struggle, which adds burden on caregivers. Results from a randomized controlled trial published in April 2021 found that this formulation does indeed help in that respect. Investigators found a marked decrease in self-reported caregiver strain after 3 weeks of treatment.1 Moreover, data presented by the manufacturer show that the effect of Jornay PM lasts through the school day and into the evening.2
In April 2021, the FDA approved viloxazine (Qelbree) for treatment of ADHD in patients aged 6 to 17 years.3 Like atomoxetine hydrochloride (Strattera), Qelbree is a selective norepinephrine reuptake inhibitor (SNRI). These drugs join the alpha-2 agonists (eg, clonidine hydrochloride extended-release [Kapvay], guanfacine extended-release [Intuniv]) as options for families who do not feel comfortable giving children Schedule II stimulants or for patients for whom substance abuse is a concern.
Like other SNRIs used to treat depression, Qelbree and Strattera carry black-box warnings about an increase in suicidality in the first months of treatment, particularly among teenaged patients. Psychiatrists should remember that many drugs carry this warning and treatment benefits may well outweigh the risks. Antidepressants show a 2% greater incidence of suicidality than placebo, and use of these medications has been not associated with successful suicide attempts.4 However, these medications are generally less effective than stimulants in treating ADHD. Patients who are not responsive to either stimulants or nonstimulants alone may be helped by combination therapy.5
Devices and Digital Therapeutics
The FDA has also recently approved 2 devices for treatment of ADHD in children. Clinicians should note that the standard for FDA approval is lower for devices than for drugs. Although drugs must prove both safety and efficacy, devices need only prove safety.
The first device is the Monarch external Trigeminal Nerve Stimulation (eTNS) System, a trigeminal nerve stimulator. Unlike the vagal nerve stimulator used to control epileptic seizures, this therapy does not require surgical insertion. The trigeminal nerve stimulator sits on the face. A small-scale study using data from the device manufacturer suggests that about half of pediatric ADHD patients responded to use of this device.6
In the digital therapeutics category, the FDA has also approved use of a video game called EndeavorRx to treat ADHD. The sensory stimulus and motor challenges of the game target the neural pathways that govern focus and attention. Studies sponsored by the device’s manufacturer suggest that the prescribed use of the game improves attention and has few adverse effects.7
Either or both of these devices may prove to be valuable adjuncts to medication and behavior management. More evidence of effectiveness would be helpful in guiding clinical decisions.
Side Benefits of the Pandemic
One of the most important developments in ADHD treatment is not a device or medication, but the rise of telemedicine. Early in the COVID-19 pandemic, most large private insurance companies and the Centers for Medicare & Medicaid Services (CMS) waived the requirement that patients be seen in person—even when those patients are being started on Schedule II stimulants. Telehealth visits offer advantages, particularly when it comes to evaluating patients’ functional abilities. Some psychiatrists prefer to see children in their natural setting, where children are often quite a bit more hyperactive than they are in a doctor’s office.
Another odd benefit of the pandemic is that many children with ADHD have developed an increased appreciation for going to school. Patients with ADHD tended to struggle more with remote learning than their non-ADHD classmates. There are too many distractions at home, including the option of playing a video game while appearing to be in the virtual classroom. Most children with ADHD simply find it easier to concentrate when they are physically in school, and many patients with ADHD say they are glad to be back in school. That is not something they would have expressed before the pandemic lockdown!
Dr Greenhill is a practicing child and adolescent psychiatrist in the San Francisco Bay area. As a member of the faculty of The REACH Institute, he co-leads the institute’s 3-day course that trains pediatric primary care providers to diagnose and manage common mental health conditions.
1. López FA, Faraone SV, Newcorn JH, et al. Effect of delayed-release and extended-release methylphenidate on caregiver strain and validation of psychometric properties of the Caregiver Strain Questionnaire: results from a phase 3 trial in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2021;31(3):179-186.
2. Gomeni R, Komolova M, Incledon B, Faraone SV. Model-based approach for establishing the predicted clinical response of a delayed-release and extended-release methylphenidate for the treatment of attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2020;40(4):350-358.
3. D’Arrigo T. FDA approves Qelbree for ADHD. News release. American Psychiatric Association; May 20, 2021. Accessed November 20, 2021. https://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2021.6.12
4. Cuffe SP. Do antidepressants increase the risk of suicide in children and adolescents? J Am Acad Child Adolesc Psychiatry. 2004;44(5):405.
5. Treuer T, Gau SS-F, Méndez L, et al. A systematic review of combination therapy with stimulants and atomoxetine for attention-deficit/hyperactivity disorder, including patient characteristics, treatment strategies, effectiveness, and tolerability. J Child Adolesc Psychopharmacol. 2013;23(3):179-193.
6. Loo SK, Salgari GC, Ellis A, et al. Trigeminal nerve stimulation for attention-deficit/hyperactivity disorder: cognitive and electroencephalographic predictors of treatment response. J Am Acad Child Adolesc Psychiatry. 2020;60(7):856-864.e1.
7. Kollins SH, DeLoss DJ, Cañadas E, et al. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. 2020;2(4):e168-e178. ❒