Emerging Treatments and Unmet Needs in Pediatric ADHD

Theresa R. Cerulli, MD: I’ve been subspecialized within ADHD [attention-deficit/hyperactivity disorder] for about 20 years, so it’s been exciting to see all the changes and improvements and the wonderful advancements in the field. But we’re not done. There’s more to come. I just explained how viloxazine, as a new chemical entity, has a very specific labeling by the FDA. It’s not easy to achieve. It must be something novel and different. With viloxazine, it’s new and exciting to me.

What’s still to come is that the adult data have been completed and submitted to the FDA. What we’ll see, hopefully by April 2022, is a response from the FDA, whether viloxazine gets approved for use in adults. I see a wonderful opportunity there. We have only 1 drug FDA approved for adults as a nonstimulant to treat ADHD, and that’s atomoxetine. That was a long time ago. That’s when I started in the field, and we’re going back over 18 years since we had another option. Hopefully, we’ll have another option for adults.

Here we’re talking about the risk with substance abuse. This comes up for me. The exciting news is that viloxazine may also be approved for adult use. We have only 1 other medication right now, and that’s a nonstimulant. This comes up in professional sports, for example. I work with MLB [Major League Baseball]. When I’m evaluating players for ADHD, because so many of the medications prescribed are stimulants and are banned substances because of the performance enhancement possibilities, that leads to abuse. For some people it’s highly regulated. Most of the time, players have to try a nonstimulant first and fail that before they qualify for trying a stimulant medication, regardless of whether they have the diagnosis accurately documented. The reason is to prevent abuse. We don’t want to go down that road if we don’t have to.

For adults who need an alternative, I just gave you a clear example that comes up in my clinical practice. The option of having a second choice besides atomoxetine for treating adults with ADHD in a nonstimulant fashion on the horizon. Besides that medication in the pipeline, there was 1 recently approved in 2021 that’s also interesting. It’s a prodrug methylphenidate formulation that just became available this year. Most people haven’t even heard of that. You’ve already had a prodrug amphetamine for many years, and that’s lisdexamfetamine. In the amphetamine family, there’s been a prodrug stimulant, but we hadn’t had 1 in methylphenidate until this year.

I’m seeing some progress in using technology to collect objective information in brain functioning and behaviors. Collecting objective information may help with our diagnostic options and approaches. For example, a company in California approached me that’s looking at using eye-tracking technology and measurements to assess and diagnose ADHD. There’s some information to show the way an ADHD person eye tracks and follows targets regarding their cognitive function compared with a non-ADHD individual. Right now, that technology is used in other ways. It is used in professional sports. It’s been used in the military. It would be interesting to find out where the cutoffs are between ADHD and non-ADHD in such objective measures so that maybe we can improve our diagnostic protocol.

Transcript edited for clarity.