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Solriamfetol could potentially serve as a new ADHD treatment if future research goes positively.
A new study found that solriamfetol, a medication approved by the US Food and Drug Administration (FDA) for several sleep conditions like narcolepsy and sleep apnea, has properties that can treat ADHD symptoms.
Craig Surman, MD, director of the clinical and research program in adult ADHD at Massachusetts General Hospital and associate professor at Harvard medical school, led the study. He also serves as co-chair of the professional advisory board of the nonprofit, CHADD, a resource aimed to educate people about the best practices to live with ADHD and how to get diagnosed and treated.
In the study, Surman and colleagues tested adults with ADHD in a randomized, double-blind trial. Some participants received solriamfetol and others received a placebo pill. The study showed that solriamfetol treatment can effectively heal ADHD as participants taking solriamfetol had less ADHD symptoms than the control group.
In an interview with HCPLive, Surman discussed the rationale behind the study, how the drug solriamfetol compares to already approved ADHD medications, and the process of getting the drug approved by the FDA.
HCPLive: What made you decide to conduct the research?
Surman: We've known for a long time that the current treatments just aren't tolerated or don't work for some people with ADHD, whether they're kids, adolescents or adults, really of any age. While many people do benefit from the treatments that are available, having more treatments available, means more people might get treated.
This compound was interesting to me because it seemed to have less potential for cardiovascular side effects or physical side effects. I thought this compound might both work for ADHD but be tolerated differently, which would mean that the people that don’t tolerate current medications might have an option for them. There's another reason as well, which is that it's less likely to be habit forming than stimulant medications…There's less monitoring that's needed to make sure that people aren't having a habit, or a new problem come from just being on the medication.
The third thing is that this compound was already approved by the FDA for individuals with fatigue, tiredness due to sleep disorders, of two particular kinds—sleep apnea, narcolepsy—and that is appealing because it means it’s already been evaluated, it's already been studied, and thought to be well tolerated and safe.
HCPLive: What does this new drug mean for people with ADHD?
Surman: It means that there may be an option for treatment with ADHD that didn't exist before. I say maybe because the FDA does not approve this for ADHD.
For folks out there with ADHD, it means stay tuned. There will be further research, probably that proves or disproves what seems to be true from this research. The size of the effects we saw was very promising, meaning how much of an effect we saw more than placebo, which gives me hope, that it wasn't just luck, that we had a positive study.
HCPLive: How does this drug compare to already approved ADHD medications?
Surman: In terms of its mechanism, it’s somewhat similar. There’s two chemicals that are approved for ADHD… dopamine and norepinephrine in the brain. What is different is its physical structure.
There’s another piece to this though, which is that there’s long been acknowledgement that people with sleep disorders may have ADHD and vice versa. People with ADHD, especially by adulthood, often have other challenges. We’ve seen some people wonder, ‘Well, is it more one or the other? Is it more that they have a sleep issue or an ADHD issue?’ and sometimes it’s hard to tell, someone will say, ‘you know, I'm brain tired, and it’s hard for me to get my work done. How different is that, then, ‘I can't pay attention right now, and get my work done.’ So there’s long been an interest in trying to understand whether waking up a brain is important for some of these patients with ADHD, as much as helping people focus more.
This drug, which has been shown to help people with fatigue and sleep… it’s showing benefit for ADHD symptoms, as well. It helps us think about that this intersection of their sleep problems and ADHD problem.
But another way, there's people with narcolepsy, who might think they have ADHD, but they’re actually just so tired, and they don’t know that because they don't know what it's like to not be tired. And this drug is approved for that. So, there’s an interest in the future of being able to better identify who needs one drug versus another. Because it could be, for example, that many people with ADHD can use a non-stimulant medication that different class of medications, and even this one, that doesn't wake you up. But other people with ADHD, maybe they need a medication, but also wakes up the brain…and has that stimulant effect.
This is the first study that tried to disentangle whether effects that we have on ADHD are in part due to improvement in alertness. So, it’s a nuanced thing. But the bottom line for the future may be that with further study, we’re able to pick which drug is right for a person based upon presenting characteristics like: Are they well-refreshed when they sleep?
HCPLive: The report said this new drug can effectively treat ADHD in adults. What about anyone under the age of 18? How much more research needs to be done?
Surman: We need to replicate this study with larger studies and then get an FDA approval and then clinicians can use it. It’s hopeful so far, from the study we did…You’d want to look at the safety and children when you're evaluating ADHD treatments. We don't know the effects of this drug in children. I expect it would be similar, but that would have to be proven.
HCPLive: Can you talk a little bit about the ill effects and how that would affect the drug getting approved by the FDA or not?
Surman: The side effects that occurred were similar to ones we see with other medications that people are treated with a for ADHD. But [if] we're comparing in general, it was less of those side effects… It was mild for everybody, except for one person that had a rash, which made them stop taking the medication. That's something that's known that can occur on this medication. In fact, on many medications, people can have allergic reactions or rashes.
The piece that was most interesting to me was that we didn't see evidence of a change in heart rate or blood pressure compared to placebo. I do need to say that it could be that higher dosing is what’s required to produce those side effects, and it may be that in the real world, people want to use higher doses.
In terms of side effect profile, it’s still thought to be less miss-usable, or abusable. Because the FDA is classified a DEA rather as their enforcement agency is classified as a schedule for drug not a schedule to drug like the stimulants. For FDA approval, you typically need a larger study. In this day and age, you need to study children. And those, the information needs to be submitted to the FDA for review, and the FDA will decide if even more studies need to be done. But it's a process that can take time. I'm hopeful on the other end of it, we may have a new option for treating ADHD.