Novel Therapy Approach to Managing ADHD



Theresa Cerulli, MD: We’ve talked a lot about what we’ve had to date for the pharmacological treatments that we’re going to combine with our nonpharmacological. You’ve alluded to the pipeline options. Frank, I know you have been very involved in watching the evolution of SPN-812. We don’t have a drug name yet because it’s still in development and in the pipeline. Prior to FDA approvals, we don’t have a name we can share. So SPN-812, what can you tell us about this novel treatment? I say novel because I really want to emphasize here that we have not had a medication in the last decade with a different mechanism of action. We’ve had different delivery systems; we’ve had novel therapies. When I say delivery systems, whether it’s beaded or coated tablets or patch or dissolving, orally disintegrating tablet preparations, delivery systems have changed, but we haven’t had a different mechanism of action. Laying the groundwork, Frank, tell us about SPN-812.

Frank Lopez, MD: Well, I have to tell you, even though I did not participate in the clinical trials, and I want to get that out there right away, I have been involved in consulting with folks who make SPN-812. It’s really interesting because this is the first time we’re seeing a mechanism of action that involves not only dopamine and norepinephrine but also serotonin. You have a really novel, modulating molecule for these neurotransmitters. You were alluding to the planning and the attention and the sequencing of the actions; that’s all dopamine related. But what about norepinephrine, which actually helps or directs arousal modulation to a great extent? Then you also have cognitive processing that’s associated to norepinephrine and sustaining the attention. You can see the elements that are going into ADHD [attention deficit hyperactivity disorder].

More important, what about serotonin? We haven’t really talked about serotonin for ADHD per se, and it’s very much a player in terms of the management of depression and anxiety, sleep and emotional regulation. But there’s more to it. It’s not just 1 or 2 neurotransmitters but actually a group of neurotransmitters, and they all balance out one another. It all starts in the prefrontal cortex, and it goes all the way down to the cerebellum through different pathways. But the important piece, as you are bringing up, is that this is a novel molecule. It is a novel molecule because it’s modulating all these neurotransmitters.

What’s neat about it is its safety profile. The data that I have seen—I think I’ve seen pretty much everything that’s been made available based on the clinical trials over a period of 5 years—are incredible. We have not had any reports of negative cardiac manifestations. We’ve not had the appetite suppression that we have seen with other medications. We do have some sleepiness, but that’s OK because it’s something that people with ADHD can benefit from, especially if they have sleep disorders.

Theresa Cerulli, MD: We forgot to mention that sleep disorders is another common comorbidity with ADHD. I wanted to throw that in there. Absolutely, it comes up a lot.

Frank Lopez, MD: Again, this would be a benefit, OK? What I was thinking more about is the fact that because it’s hitting the serotonin, we’re getting some positive benefits for those individuals who have coexisting comorbid complex ADHD with signs of anxiety and maybe even depression.

Theresa Cerulli, MD: Let me clarify. My understanding about SPN-812, it’s in the pipeline for a treatment option for ADHD.

Frank Lopez, MD: For ADHD.

Theresa Cerulli, MD: But the novel mechanism you’re talking about is that there may perhaps be more to the ADHD story than just dopamine and norepinephrine, because here we have an agent that’s also modulating serotonin.

Frank Lopez, MD: Correct.

Theresa Cerulli, MD: That has shown in the clinical trials efficacy for ADHD.

Frank Lopez, MD: Absolutely, and that’s really very critical.

Theresa Cerulli, MD: What’s exciting to me, and I’m going to wear both my professional hat with my patients, but as a parent with ADHD—a lot of the times, we’ve been talking about comorbidities, and so the challenges that we see so often are when you go to treat the core ADHD symptoms, stimulants and nonstimulants, that sometimes you end up making the comorbidity worse, particularly with anxiety. When the anxiety is a comorbid condition, a lot of times the stimulants, which work beautifully for ADHD, you may worsen the anxiety. To have an agent that can modulate dopamine, norepinephrine, and serotonin may create some hope for those of us who are seeing the comorbidities that 75% of the time in practice, and have had the challenge of addressing what is so commonly a clinical problem in addition to the core inattention and hyperactivity and impulsivity.

Frank Lopez, MD: I completely agree with you. I think that this medication, which is in the process of being reviewed through the FDA at this point, holds a lot of promise, because of the things that you have said but also because of the novel approach to modifying these 3 neurotransmitters. I can’t underscore that enough. That, to me, is very exciting.

Theresa Cerulli, MD: At the very least, probably some hope around at least not worsening comorbidities, right?

Frank Lopez, MD: Right.

Theresa Cerulli, MD: We don’t have data, we’re just speculating based on mechanism of action. We have another option. We have an option we haven’t had previously if the drug does get approved in terms of its approach. That unique thumbprint in the brain of ADHD, we also might have a unique option for addressing some of the things we haven’t been able to previously.

Frank Lopez, MD: One hundred percent.

Theresa Cerulli, MD: We’ll see how this pans out. I think November is when they’re expected to be reviewed by the FDA.

Transcript Edited for Clarity

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