Q&A: What Pharmacists Need to Know about Onyda XR for the Treatment of ADHD

Clonidine hydrochloride (Onyda XR) was approved by the FDA in May 2024 for the treatment of ADHD in pediatric patients 6 years of age and older. The medication, which is now available in the United States, is a once-daily, extended release, oral suspension medication and is the first liquid, non-stimulant for ADHD approved in the country.

Q&A: What Pharmacists Need to Know about Onyda XR for the Treatment of ADHD / ClareM - stock.adobe.com

Developed by Tris Pharma, Onyda XR can be used as a monotherapy or as an adjunctive therapy to an approved central nervous system stimulant. The availability of Onyda XR could potentially help alleviate some of the treatment challenges patients with ADHD have been facing, including an ongoing shortage of stimulant medications.

Drug Topics recently sat down with Rakesh Jain, MD, MPH, clinical professor in the Department of Psychiatry at Texas Tech University School of Medicine, to discuss the growing prevalence of ADHD, the importance of Onyda XR, how the medication fits into the broader ADHD treatment landscape, how to help children with ADHD get the treatments they need, and some important things that pharmacists need to know about the new therapy.

READ MORE: Onyda XR, First Liquid Nonstimulant for ADHD, Now Available in US

Drug Topics: Can you discuss the growing prevalence of ADHD and any reasons that may be causing it?

Rakesh Jain, MD, MPH: Two comments. First, you're completely right. ADHD prevalence is indeed rising. The big concern is, are we over diagnosing it? And here's the perhaps good news; generally speaking, we are not. That begs the second question, what's going on? Why are we seeing so much more ADHD…I don't have a very good answer for you, other than to perhaps point out, this is a genetic disorder, and perhaps there are reasons that this amplification of this disorder may be happening because of enhanced stress levels, enhanced levels of divorces in the society. But please remember, I'm just hypothesizing here, we don't know. And as I travel around the world and I meet with my international colleagues, they are saying the same thing. It's a global phenomenon.

Drug Topics: Can you discuss the importance of Onyda XR and how it fits into the broader ADHD treatment landscape?

Jain: Yeah. Onyda XR is clonidine [hydrochloride] extended release liquid formulation once a day. Clonidine off label has been used for, I'm going to say about 40 or 45 some years, in psychiatry. Where did it fit in? In some people as monotherapy for the treatment of ADHD symptoms, and in many others as combination treatment, because even our great stimulants aren't enough in helping every single person. So, where does it fit in? It's a very good question. Because we have a once a day, a true once a day formulation, I think we're going to use it 2 different ways. I think we'll use it in combination with stimulants when the stimulant isn't adequate or because there are side effects that the stimulant medication is causing, such as sleep problems or agitation or activation, or if they're inadequately controlled symptoms, typically impulsivity and inattention. But there are going to be some kids where we simply don't want to use stimulants. We prefer to use non-stimulants. The good news is this drug is approved in that fashion too. I am pretty pumped up about it. Way before this drug was born, I was an extensive user of clonidine because I really, really, really try and aim for as close as I can to the perfect control of symptoms of ADHD in all my patients.

Drug Topics: There has been an ongoing shortage of ADHD medications for quite a few years. How can Onyda XR help with this issue?

Jain: The shortage is getting better. It's not a catastrophic situation. It was a catastrophic situation. It's getting better. The DEA has said they're not going to dramatically increase the availability of stimulants. They're going to make some changes, but not dramatic. How does this medication fit in? Well, it could fit in by perhaps using this as first line. There are many kids where stimulants are not first line. What if the kid has lot of sleep difficulties and is underweight and has ticks? What do you do then? I think now that we have a once a day clonidine preparation available, we should consider that. But the other thing could be, we could use less of a dose of a stimulant because Onyda XR is being used right alongside it. I don't think the goal here is to replace stimulants, but it's to appropriately use the right drug in the right context, but also to use 2 medications at the same time, when it is so appropriate. And clearly the FDA sees eye to eye with what I'm saying, because the approval of this medication is in both ways, as a monotherapy or in combination with stimulants.

Drug Topics: According to a 2022 CDC national survey, 30% of children with ADHD didn't receive medication or behavioral treatment. What do you think can be done to help children get the treatment they need?

Jain: Many of them don't receive it because they're often too afraid of stimulants. They or their parents are. For them to know we have a non-stimulant option that they can just take once a day, and it's expected to work all day, and that is even a liquid formulation that we can ingest pretty quickly, that might bring the fence sitters over to the right side on the treatment side. But the other thing we need to do, and actually we're doing that right now, which is to propagate the message that ADHD is a serious disorder. It's not the acne of mental health. It's a very serious disorder that significantly harms the life of children and adolescents and adults, and to treat it through whatever appropriate means necessary is incumbent upon the person and the family members. That's my message to folks, that if you are sitting on the fence worrying about stimulants, we now have a non-stimulant option. If you're worrying about the risk of over diagnosis, I get it. I genuinely get it. Maybe seek a second consultation, but please do not make the mistake so many of my patients do make and then regret it down the road. They often have told me, “I am just so sorry I waited the extra 5 years or 10 years. My child's life, because I waited so long, has been shaped in the negative.” We don't want that.

Drug Topics: Onyda XR recently became available in the United States. What are some important things pharmacists should know about the medication?

Jain: [Pharmacists] need to appreciate that this is the world's first liquid, once a day, extended release formulation. So, it's going to be new for them, but they need to appreciate it's new for the patients as well. Patients might be confused. [They] take it just once a day. It's a liquid. How do [they] even measure it? Can [they] take it twice a day? I think following the package insert closely would be a very good idea. I think the pharmacists need to realize that, because this is in so many ways revolutionary, they should be supportive of the parents desire. Because, on occasion, and I have to I have an honest talk with my pharmacy colleagues sometimes, when I write prescriptions for medications for ADHD, they sometimes without meaning to directly or indirectly try and talk the parents out of it because of their own personal belief system or biases. I want to tell my pharmacy colleagues that this is a non-stimulant medication. This has a long track record. This has an FDA approval. It is extended release. Look at the side effect profile, look at the benefit profile, look at the novelty aspects of it, and think about ways that they can genuinely embrace this significant positive development in the field.

Drug Topics: Is there anything else that you would like to say on the topic of ADHD or Onyda XR?

Jain: There's ADHD in my own family. I'm going to put aside my clinician role, just as a human being, I actually have a lot of sympathy for both the patients who have ADHD and their family members. They're often not given the respect by society that you would give someone if they had breast cancer or they had COVID-19. We just don't do that. First things first, I respect the plight that you are in. I really do appreciate it. The second thing I would say is stimulants really are remarkable medications, but sometimes as many as a third of the time they are not appropriate as first line. Now, we've got a genuine, highly patient-centric way to treat the disorder. The second thing I want people to remember is sometimes you use this medication by itself, but you can even use it with stimulants, with the goals being to further the improvement and hopefully even counter the side effects. There is no magic formula, but the magic is when the patient, the family and the clinician, when this triangle, when it works well together, we do some really, really good things to help people long term. This is a significant innovation in ADHD treatment and everybody, clinicians, pharmacists, payers, parents, patients, I think we should give this a very close look to see if it fits our needs.

READ MORE: Mental and Behavioral Health Resource Center

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