In this video, a psychiatric physician assistant with a doctorate of medical science will review the proven Phase III efficacy and demonstrated safety and tolerability of a nonstimulant medication in clinical trials of children and teens with ADHD. She will also review the long-term and open-label extension data for this nonstimulant ADHD treatment.

Please see full Prescribing Information, including Boxed Warning.

Jo Hughes, PA-C, CAQ-PSY, DMSc: Hi, everyone. My name is Jo Hughes, and I'm a psychiatric PA, coming to you from Greensboro, North Carolina. And today, we're going to talk about Qelbree, a novel nonstimulant that works.

Qelbree is approved for the treatment of ADHD in patients 6 years and older.

Narrator: INDICATION
Qelbree is indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.

IMPORTANT SAFETY INFORMATION
Warning: Suicidal thoughts and behaviors. In clinical studies, higher rates of suicidal thoughts and behaviors were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

CONTRAINDICATIONS

• Concomitant administration of monoamine oxidase inhibitors (MAOI), or dosing within 14 days after discontinuing an MAOI because of an increased risk of hypertensive crisis.

• Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range.

Please see accompanying full Prescribing Information, including Boxed Warning and full Important Safety Information, at the end of this video.

Jo Hughes, PA-C, CAQ-PSY, DMSc: The learning objectives for the day. We’re going to talk about the straightforward, once-daily, flexible dosing of Qelbree, the first novel nonstimulant for pediatric ADHD in over a decade. We're going to review Qelbree’s proven efficacy, safety, and tolerability profile in clinical trials in a pediatric patient 6 years and older with ADHD. We're going to discuss the long-term, open-label extension data for Qelbree and pediatric patients.

We're going to review Qelbree’s proven efficacy, safety, and tolerability profile in clinical trials in pediatric patients 6 years and older with ADHD.

Qelbree Phase 3 studies assessed efficacy and safety. In children 6 to 11 years old, the screening was started at 1 week washout prior to week 2 of starting, then 1 week of titration, either 100 mg or placebo, and then the maintenance week of 5 weeks that could be either 100 mg, 200 mg, or placebo, and then measured with the primary endpoint at 6 weeks.

Adolescents 12 to 17 were studied, with a 1-week washout prior to the visit 2. And then at week 1, there was either a 200 mg arm, a placebo arm, then a week later, were titrated either to 400 mg, stayed at 200, or stayed at placebo.

The primary endpoint was change in an ADHD-RS-5 screening tool from baseline to the end of study at 6 weeks.

Let's look at the proven efficacy in treating children 6 to 11 years. The primary endpoint was looked at at week 6. And again, this is a change from baseline in the ADHD-RS-5 score.

You can see here on the left in the graph that a statistically significant difference was noted at week 1 in the 100 mg arm and the 200 mg arm. And you can see out to week 6 that this continued to be seen as also statistically significant.

To the right, you can see that they were looking at both inattention subscale and hyperactivity/impulsivity subscale. And this shows us in the Qelbree arms, inattention and hyperactivity/impulsivity symptom score reduction observed as early as 1 week.

Let's take a look at the proven efficacy in treating adolescents 12 to 17. Again, the primary endpoint is similar to the children, looked at week 6, and a change from baseline in the RS-5 total score. We see a statistically significant change at week 2 on the left there. On the right, you can see they were also measuring the subscales inattention and hyperactivity/impulsivity.

Let's look at the safety profile for children and adolescents. What were the most common adverse events reported?

Somnolence was reported more, so was decreased appetite and fatigue. But again, when I'm looking at adverse events, I always think, all right, these happen, I want to know about them, but how many children and adolescents stopped the trial because of these adverse events? So, I love to look at the discontinuation rate. What did that look like?

And here we can see in the Qelbree arms, 3% versus 1% of placebo stop the trial because of these side effects. There’s no hepatic warnings, and there was no clinically significant elevation of LFTs reported in patients receiving Qelbree.

Now let’s look at the open-label extension trial, which was designed to assess long-term safety and efficacy in children and adolescents with ADHD. So these participants that were in the phase III trials were allowed to continue if they wanted. They got dose optimization up to 12 weeks, and then they were watched for up to 72 months and evaluated every 3 months for safety and efficacy, discontinuation, and/or adjustments that were needed.

The primary safety objective was collected to look at the long-term treatment of children and adolescents with Qelbree. There's also a secondary efficacy objective. Did it continue to work for all these patients?

The primary safety focus of the open-label extension interim analysis in pediatric patients demonstrated no new safety signals after 72 months, and 8.1% of the participants discontinued due to adverse events.

All right, we covered the primary objective, which was safety. Now let's look at the efficacy of the long-term response with treatment on Qelbree. Again, we're looking at the ADHD-RS-5 total score and a change from baseline.

On the left of the screen here, you can see where the phase III trials were, the 6 to 8 weeks. Then we have the optimization period up to 12 weeks. After the optimization period of up to 12 weeks, we look out at the long-term response of Qelbree. And I want to point here at the very right, this analysis showed a 66% change from baseline in the ADHD-RS-5 total score in patients with long-term treatment on Qelbree.

All right, we've looked at the data. Now, let's talk about how we get started prescribing Qelbree. First, let's look at Qelbree dosing in pediatric patients with ADHD.

In children 6 to 11 years, the starting dose was 100 mg. It was titrated over 1 to 3 weeks as needed to reach effective dose.

In teens 12 to 17 years, the starting dose was 200 mg a day and was titrated over a week as needed to reach effective dose. The maximum dose was 400 mg a day.

Seventy percent of children and 65% of teens were optimized at Qelbree with a dose of 300 mg a day or greater. When seeing our patients, we need to set expectations with any medications. And with Qelbree, we can talk about flexible dosing. It can be taken in the morning or at night. We can optimize efficacy with weekly titration as needed.

And a combination of these factors can help patients navigate potential treatment barriers. Talk about the efficacy as early as 1 week seen in the pediatric patients 6 to 11, and as early as week 2 for adolescents.

Consider asking about daily activities as they adjust to different internal cues and the responses to Qelbree. For example, did you remember your book bag? Did you remember to bring your homework home? Which I find to be a big one, especially in the adolescent population.

Discuss the most common adverse events patient might experience while taking Qelbree.

Utilize the flexible dosing of Qelbree to create a management plan for potential adverse events.

Talk about drug-drug interactions. Talk about no drug-drug interactions with amphetamines or methylphenidate.

No Qelbree dose adjustments required for concomitant use with CYP2D6 inhibitors and poor metabolizers. We have to be a little careful in that Qelbree is a strong inhibitor in and of itself. So, we have to watch for those sensitive CYP1A2 substrates and CYP1A2 substrates with narrow therapeutic margins. That is contraindicated with Qelbree.

It's general good practice to check vitals in our psychiatric patients, and Qelbree is no different. So in the studies, Qelbree caused an increase in diastolic blood pressure and heart rate. As clinicians, we need to measure this at the start of therapy, during dose changes, and periodically during therapy. But I want to point out that although this was an increase in some of our patients, 2 patients in the children and adolescent study stopped the study due to tachycardia.

Qelbree can be conveniently prescribed and refilled without a new prescription every month.

Here's some interesting data showing patients who initiate Qelbree treatment; 68% had prior ADHD treatment, and 32% were new therapy starts. Look to the right here, and you can see where patients switched to Qelbree, what medicines they were on before. Fifty-five percent were on stimulant sources like Vyvanse, amphetamine, methylphenidate. Forty-five percent were on nonstimulant sources like Strattera, Intuniv, and others.

Supernus is committed to supporting patients with ADHD and their families. I love to be able to give samples to my patients. This is great with written instructions and a wonderful support program. Qelbree is covered across 75% of commercial insurances. Your sales representative will have access to the materials that you can give and provide you samples upon request.

In my practice, I find Qelbree to be very effective. I've had great success with these patients—children, adolescents, and adults. You can learn more at QelbreeHCP.com.

Indication and full ISI scroll at the end of the video.