David W. Goodman, MD, leads a discussion on the use of viloxazine for the treatment of adults with ADHD.
Theresa R. Cerulli, MD: We’ve been talking about more treatment of viloxazine in children. My understanding is that the adult studies are not only completed but in the hands of the FDA with regard to treating adult ADHD [attention-deficit/hyperactivity disorder] with viloxazine. Birgit and David, perhaps you’d like to weigh in on the treatment of adults with this compound. What are your thoughts?
David W. Goodman, MD: The data haven’t been published. I don’t want to overpromise and underdeliver. That was the shortcoming that happened with atomoxetine. Clinicians ought to keep in mind that there’s a place for nonstimulants. We’ll see what the adult studies show. Obviously, they were submitted, so they’re going to be positive. I’ll highlight that the history has been effect-sized for nonstimulants as well as stimulants as higher in children and adolescents than it is in adults. I anticipate a similar outcome in regard to comparative effect sizes. We’ll see.
The drug interactions are a consideration much more in adults because adults are on polypharmacy and other medications. Caffeine is very important. If you assume that your elevated tachycardia or blood pressure is a function of medication and not elevations in caffeine levels as a result of A12 inhibition, you’re going to be diagnostically misdirected in stopping the viloxazine. We’ll wait and see. For the adverse-effect profile, we’ll have to see. It’s often different in adults from children. Children are more sensitive to some of the adverse effects, and adults are less sensitive but may have other adverse effects. We’ll see. I’m optimistic. I’m glad to have more options. There are 15% of patients who aren’t responding adequately to what we have available with the stimulant medication, so we need more options.
The other option for adults that was recently approved is an amphetamine extended-release tablet. We can spend a moment talking about that. They have adult trials. They’re approved for adults. This is amphetamine racemic mixture; it’s a tablet, long-acting, and chewable. They have a study in adults that’s out to 13 hours that showed improvement in the PERMP [Permanent Product Measure of Performance] score, which is a test of mathematics and how many math problems you can do in a period of time. They had an onset at 30 minutes and extended at 13 hours. If we come back to the other stimulant medications, with a thoughtful process of what compound are you going to choose, what delivery system are you going to choose? How you are going to develop a combination? There isn’t a lot of combination therapy with stimulants and nonstimulants, and I hope that develops because the atomoxetine stimulant trials were very useful for clinicians treating patients who aren’t responding adequately to 1 treatment or another.
Theresa R. Cerulli, MD: Birgit, I believe I heard you say that you have had some experience clinically using viloxazine in adult patients with ADHD. Any thoughts to add?
Birgit H. Amann, MD: I have. It’s been limited because we’ve been met with difficulties with the insurance companies letting it go through, so I’ve been having to sample them. I’m hopeful, fingers and toes crossed. It won’t be difficult to begin to use in adults, no different from use in the child and adolescent population.
Theresa R. Cerulli, MD: I’d like to share 1 of the few adult patient stories that I’ve heard in using viloxazine in my own practice. As you said, for a few patients the coverage has been challenging because we don’t have the approvals. The feedback from this patient was just so powerful. By the way, I often ask that question to patients: what does it feel like to take this medication? That’s a question that doesn’t get captured in the data but that we very much care about in our day-to-day practices. This patient responded to me. She’s in her mid-30s and definitely not a simple ADHD case. It’s a complex case, with multiple comorbidities. At least 2 come to mind. She hadn’t been comfortable taking stimulants previously because of her complex situation. On her first visit after she started on Qelbree, her words were, “Instead of walking through an old home with cobwebs hanging from the ceiling, it felt like those cobwebs parted, and there was a very clear path for me to think.”
Rakesh Jain, MD, MPH: Wow.
Theresa R. Cerulli, MD: That was the description she gave me. I wanted to share that because this isn’t something you’re going to see reported in the studies. But that’s what it sounded like. Rakesh Jain, as you were saying, each patient ADHD is a patient with ADHD, and that’s it. Everyone is unique, but that was my experience. It’s worth taking a look at. At this point, what I’m hearing sounds different from what I’ve heard on other medications, whether we’re talking about stimulants or nonstimulant medications.
Birgit H. Amann, MD: Beautiful example.
Transcript Edited for Clarity