Novel Delivery Systems Utilized in the Treatment of Adult ADHD - Episode 9
Theresa Cerulli, MD, discusses the practical considerations for using serdexmethylphenidate-dexmethylphenidate for the treatment of attention-deficit/hyperactivity disorder.
Theresa Cerulli, MD: It’s interesting that we have prodrug that’s schedule IV. It doesn’t exist by itself, but when I gave a talk, somebody asked, why don’t we have just a serdexmethylphenidate? The FDA has looked at serdexmethylphenidate, the prodrug portion, and said that it doesn’t have the drug-liking effect. They compared it with phentermine, which is a schedule IV. The serdexmethylphenidate itself is controlled at a schedule IV level. It’s very interesting. But it doesn’t exist by itself. It’s part of the Azstarys medication.
They did compare the drug-liking effect of immediate-release dexmethylphenidate with serdexmethylphenidate, both the low-dose 120 mg and high-dose 240 mg of serdexmethylphenidate compared with placebo and immediate-release D-amphetamine. The serdexmethylphenidate dosages were very similar to the placebo in their liking effect, while immediate-release dexmethylphenidate had a much higher liking effect and therefore has the abuse potential classified as a CII [schedule II] like other stimulants.
Anthony Rostain, MD, MA: That’s really important. As we know more about its effect in adults, I imagine we’re going to look and see. It’s good that it’s not liked by drug users, so the next question will be how can we assess its role? It will play an important role. I like dexmethylphenidate as 1 of the best of the methylphenidate preparations for adults with ADHD [attention-deficit/hyperactivity disorder]. This will be even better because the duration of action will be longer.
Theresa Cerulli, MD: It is. I was referring to the PK [pharmacokinetic] curve. But the study of Azstarys did look clinically at how these kids are doing in terms of their ADHD symptomatology. The SKAMP [Swanson, Kotkin, Agler, M-Flynn, and Pelham] scale was used as the primary outcome measure, and the secondary end point was the PERMP [Permanent Product Measure of Performance] math test that they give kids throughout the laboratory classroom day to see how they’re objectively performing They looked at problems attempted and solved on the math test, and both showed statistical significance over placebo throughout the course of the laboratory classroom day.
Anthony Rostain, MD, MA: Yes, it was quite impressive. I’ve seen the data. They look great.
Theresa Cerulli, MD: Some of the first patients I had used Azstarys on were those who were taking a combination of dexmethylphenidate extended-release Azstarys with a booster IR [infrared].
Anthony Rostain, MD, MA: Yes, at the end of the day.
Theresa Cerulli, MD: Yes. That made the most sense. People who were looking for that knew that they responded well to dexmethylphenidate and were happy with the product, but it wasn’t lasting long enough. Those were the first ones who transitioned over. I’ve had others who had adverse effects on their dexmethylphenidate extended release. One had some issues with heart rate increases. Azstarys didn’t exist at the time. We had tried an amphetamine-based stimulant and a couple of other things instead. It was very clear that dexmethylphenidate was the molecule that worked best. We were back to that love-hate relationship. Do you take something that has some bothersome adverse effects but works the best? Do you grin and bear it? Or do you switch and try a different category? When Azstarys came out, because the PK curve looked different and because I was getting the feedback that that smoother sense means you might not experience the same physiological outcomes, I said, “Let’s try it.” It’s been great. I’m thankful to say that the patient hasn’t had the heart rate increases. I can’t explain it. We know the way the studies are done and can quote from that. We learned from our patients. His feedback was that he’s thrilled it’s lasting longer. He’s got the efficacy he’s always had, and now he’s not dealing with the bump he was getting in terms of heart rate increases on extended-release dexmethylphenidate. That’s my patient’s story.
Transcript edited for clarity