Amphetamine XR Oral Tablets in Clinical Practice

Theresa R. Cerulli, MD: Can you expand on that a little, particularly with the amphetamine XR [extended release] oral tablet? How has it changed or improved clinical outcomes for your patients with ADHD [attention-deficit/hyperactivity disorder]? There have been other amphetamine extended-release preparations. Is there anything you can share to help paint the picture of how this feels to you in practice?

Birgit H. Amann, MD, PLLC: In practice, as we’ve talked about, I’m working really hard to try to make sure that whatever product I’m using adequately covers their day. Prior to now, without having the oral tablet version of amphetamine XR, the liquid version of amphetamine XR has done well in that regard. I’ve rarely had to utilize a short-acting amphetamine with those on the liquid form of amphetamine XR. The formulation itself has worked beautifully in the practice to offer them a once-a-day option that truly covers their day into the evening. We talked about the need to cover those driving adolescents, for example.

We’ve talked about the length of an adult’s day, and that we need to make sure to have proper coverage. I was able to do that with the liquid format, but I can also do that with the oral tablet and appease any patient concerns about not wanting to take a liquid anymore. For some patients, another reason they want to switch to the tablet is because they don’t like the taste of it. They don’t have to worry about that anymore.

Theresa R. Cerulli, MD: Dr Feld, you’re smiling. What has the feedback been from your patients?

Michael Feld, MD: It’s a very cool product. I believe in all these products that we’ve talked about. But the cool part about what Birgit said is the company studied the tablet taken while fasting, on an empty stomach, chewed, and swallowed, and compared it with the PK [pharmacokinetic] curve of the liquid at the same dose. What did they observe? The PK curves of all 4 doses landed on each other. You can’t even see them separate out. When you teach and look at the data that this company provided, you can’t even show the 4 different curves because they lie on top of each other that closely. You have no food impact.

As Birgit said, you can swallow the tablet, but you have to swallow it pretty fast because it starts to melt a little and has a little taste. But it’s very easy to get down pretty quickly if you don’t want to worry about any taste issue. You get quick onset consistently day in and day out. You can count on this delivery system, like a few others, because of the factors that we talked about: the continuous release of the molecules, lack of pH issues, and lack of food impact. You can count on taking it one day and feeling as you felt the day before.

Theresa R. Cerulli, MD: The word consistency is coming to mind with everything you’re saying.

Michael Feld, MD: The consistency is remarkable. Ask your patient, “What’s it like every day?” A lot of people don’t ask enough questions. Patients do pretty well, but they’ll tell you, “Yesterday I felt a little too flat at 2 o’clock,” or “Yesterday I crumped out at 2:30.” The point is that you want a product you can count on. The nicest part about the tablet, like the liquid, is that you have a very slow descent. My patients don’t talk about crashing. They talk about trying to figure out when it stopped working. I’m teaching them that at hour 12, it isn’t going to be as effective as hour 4 when it’s at its peak, but you still have enough mixed amphetamine in your bloodstream to get efficacy.

It’s a challenge to teach people that you’re probably still getting efficacy. As long as you feel good when you’re coming off it at hour 12, you’re better than you were the day you didn’t take it. The mixed amphetamine LiquiXR tablet has 14-hour data. We’re talking about a 30-minute onset clinically and some other data with the liquid. You’re looking at really quick onset and decent tolerability for most people. I really like it. People like the liquid because they like to flex the dose. They like to change the dose, take more on a real busy day, and take less on a weekend day when they’re just going to coach their child’s soccer or whatever.

Theresa R. Cerulli, MD: That makes me a little nervous.

Michael Feld, MD: But it would be better than not taking it.

Andrew Cutler, MD: Exactly. That’s my point earlier about adherence. At least they’re going to take it.

Michael Feld, MD: I’d rather have a partially medicated child who wants to eat a little more and likes their personality a little more than a child who won’t take their medications. I have a patient who wants to stay on the liquid. There are 8 doses with the tablet, but there are 16 possible doses with the liquid. Eight doses is still a lot for the amphetamine.

One of my patients is going to take the tablets because he travels a lot for work. He has a little bottle that he pours less than 3 ounces of the liquid into to get through TSA [Transportation Security Administration screening], but then it spills. He’s going to try the tablet and maybe be on both. We’ll see. Because the other thing I’ve learned about the tablet is that it feels more consistent for a lot of people. What if they don’t take the exact right amount of liquid every day? With the tablet, you’re getting even more consistency because you’re getting a more predictable dose when you know exactly what you’re taking. The tablet has taken the liquid to the next level.

Theresa R. Cerulli, MD: Very good point, Dr Feld.

Alice Mao, MD: When I’m considering options for treatment, I like to think about the duration of coverage that the patient needs. I ask them, “How long is your workday? What activities do you have after work that you feel you need to focus on in order to be able to complete them efficiently?” Oftentimes people will say, “I need it for 16 hours of the waking day.”

When I consider giving a medication, I ask them “Are you able to swallow? Are you able to take pills?” Because there are pills that are orally disintegrating, and other pills that are easy to swallow. Some of them are breakable so that you can have multiple doses within a certain tablet. If they tell me they’re able to swallow and that they’ve responded well to amphetamine medications, or have already taken maximum doses of methylphenidate compounds, and they’re looking for alternative options, then the amphetamine extended-release tablets are a wonderful option because there are multiple doses available, and we can tailor the dosage to the patient. They have a very long duration of 13 hours, which has been established in the clinical trials.

We’re excited that the patients can have the benefit of a long-acting delivery system, take 1 dose in the morning, and not have to worry about taking additional medications at the end of the day. My patients who were on the liquid formulations love transitioning to the tablets because they feel as though they’re making an advancement in terms of the ease and convenience of carrying the tablets with them. It’s a wonderful addition to our armamentarium.

Transcript edited for clarity