SPN-812 Tolerability Profile



Theresa Cerulli, MD: For the safety and tolerability profile, what I heard you say was that there’s less concern around cardiovascular, that it’s not separated from placebo, less concern about ECG [electrocardiogram] changes. If anything, I believe there was better than placebo, not worse, in terms of outcomes on ECG.

Frank Lopez, MD: On ECG, that’s correct. The other thing is that abuse potential doesn’t seem to be present.

Theresa Cerulli, MD: Important point.

Frank Lopez, MD: Yes, it’s a very important point, because when you have the stimulants as the gold standard, and God knows you and I have been involved in so many studies over the years, we always have that concern. When a medication is used correctly, the chance of being abused is much less. But even with a lot of monitoring and a lot of structure and a lot of support, we still have that risk. So far, in the data that we have seen, that’s not been a concern.

Theresa Cerulli, MD: Tell me, Frank, given that what we do have for medication treatment options to date can be challenging, do you recommend drug holidays for a child who takes ADHD [attention deficit hyperactivity disorder] medications?

Frank Lopez, MD: I’m going to answer that in a way that I know is going to maybe irritate some folks. But the answer to that is typically, I don’t. ADHD is a 365-day-a-the-year, 24-hour-a-day disorder, and it doesn’t take a holiday for Christmas or Thanksgiving or Easter or the summer or for COVID-19 [coronavirus disease 2019] for that matter. But at the end of the day, if a patient were to be having adverse effects, whether it’s decreased appetite or sleeplessness, insomnia in any of its forms, then we have to step back, either decrease the dose or maybe give them an opportunity to come off the medication and look for an alternative if that’s available.

Drug holidays have a place, but I don’t think that is primarily the way to go. I have colleagues who will argue vehemently with me when I say that. They’ll say, “No, the parents know what they’re doing. They know how to manage their child.” Really? Is that really true? Are you sending them for therapy? Are they getting targeted therapy? What are we doing to say that the parent really knows how to manage the ADHD child at home without medication? There may be some parents that have that, but honestly, I really strongly want people to consider giving medication throughout the course of every day.

Given that, and I’m going to bring this back to SPN-812, this actually has a fairly long half-life. It’s given once a day. So far, this medication may actually give us that around-the-clock support that we need. More important, SPN-812 has actually been studied in conjunction with a stimulant. We had some data to look at, that showed that it had been tried, had been looked at with methylphenidate and with amphetamine. And there were no negatives per se as a result of that. That opens the door—we have SPN-812, and we’re getting some good results. Monotherapy for me is always the best way to go. But sometimes we have no choice, sometimes we have to look for something else in addition. We have some safety data there, so that’s exciting in terms of the profile. But what’s more exciting to me is that this medication may serve as monotherapy for ADHD and perhaps some additional comorbidities, in particular the anxiety.

Theresa Cerulli, MD: But to clarify, it’s being looked at as a monotherapy.

Frank Lopez, MD: As monotherapy.

Theresa Cerulli, MD: As monotherapy. The trials that were done in ADHD were as monotherapy.

Frank Lopez, MD: Correct, and very large trials at that, with very low attrition rates. That’s also very important. It’s nice to have 200 kids or 300 kids in a study, but when you have over 1100 kids in clinical trials, over a period of 5 years, and the attrition rate is around 4%, that is remarkable.

Theresa Cerulli, MD: From what I’ve read, if there are going to be adverse effects to watch for, they’re generally going to be the somnolence.

Frank Lopez, MD: Yes.

Theresa Cerulli, MD: If you’re going to have an adverse effect, it’s the 1 that came up most commonly.

Frank Lopez, MD: Right.

Theresa Cerulli, MD: The other thing I’ll add, before we leave the SPN-812 topic, is that we all have our story and how we got here as ADHD clinicians, and SPN-812 has its story and how it came around to be studied for ADHD. But it was originally FDA approved in Europe as an antidepressant. I found its history to be quite interesting. When we reflect on the novel mechanism of action that you’ve described in terms of modulating dopamine, norepinephrine, and serotonin, it makes sense clinically perhaps that that’s its history, in terms of having treated a mood disorder in Europe for years before being studied here in the United States for ADHD.

Transcript Edited for Clarity

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