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

Please see full Prescribing Information, including Boxed Warning.

Jo Hughes, PA-C, CAQ-PSY, DMSc: My name is Jo Hughes, and I'm a psychiatric physician assistant with a doctorate of medical science, and I'm here to talk to you about Qelbree, a novel nonstimulant that works.

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: Today we're going to explore the first nonstimulant approved for adult ADHD in 20 years. Appreciate the straightforward once-daily flexible dosing of Qelbree. We're going to review proven efficacy and demonstrated safety and tolerability of Qelbree in the clinical trial of adults with ADHD. We're going to discuss the long-term and open-label extension data for Qelbree in adults.

The phase III study designed to assess efficacy and safety of Qelbree in adults with ADHD was a double-blind placebo-controlled trial. It included adults 18 to 65 years old with a diagnosis of 6 or more months of ADHD per the DSM-5. AISRS score were also indicated at screening and at baseline visits, and to be included in the study it had to be a score of 26 or greater.

Primary endpoint is change from baseline to end of study in the AISRS total score was noted. During the screening there was 1 week washout prior to visit 2 of patients who were included, and then from that point they went to a placebo group and the controlled group.

The controlled group started at 200 milligrams a day for a week, and they were titrated to 400 milligrams by week 2. For the next 4 weeks, the controlled group was then titrated between 200 milligrams with flexible dosing to 600 milligrams based on patient tolerability and efficacy for them. At the end of 6 weeks, they were looked at again.

Let's talk about what the AISRS score rating system is. It is an Adult ADHD Investigator Symptom Rating Scale. This is an 18-item scale directly corresponding to the 18 DSM-5 symptoms of ADHD. It is the sum of inattention and hyperactivity/impulsivity subscales. There’s 9 items that cover inattention, and 9 items that cover hyperactivity/impulsivity. Each item is rated on a 4-point Likert scale, 0 to 3—0 being none, and 3 being the most severe.

Let's look at the graph representation of the efficacy in treating adults with ADHD from this phase III trial. Again, the primary endpoint was a change from baseline at week 6 in the AISRS total score. And here we can see as a baseline of the AISRS score for placebo was 37 points and Qelbree was 38.

The y-axis indicates the AISRS score, and the x-axis is the weeks out. And what I want you to focus here on is you're seeing the placebo is the gray and the Qelbree is in the plum, and at 2 weeks we see a statistically significant separation from placebo and folks taking the Qelbree.

I also want you to focus on how inattention and hyperactivity/impulsivity symptom score reduction were also noted in the Qelbree arm.

Let's look at the safety profile from this study in adults. The most common adverse events, you can see here insomnia, headache, fatigue, and nausea are in the top 4 places compared to placebo. But let's also look at the discontinuation rates because of these AEs—9% of folks in the Qelbree arm and 5% of folks in the placebo arm. Other safety information noted were there are no hepatic warnings, in the clinical trials there was no clinically significant elevation of LFTs reported in patients receiving Qelbree.

Now, let's look at the open-label extension trial up to 3 years. It was designed to assess long-term safety and efficacy in these adult patients with ADHD. After completing the phase III trial, the adults in this study were given 200 milligrams of Qelbree a day for 2 weeks to participate in the open-label extension. After 2 weeks, then they could be titrated from 200 to 600 milligrams a day based on their tolerability and efficacy per patient. The primary safety focus from the open-label analysis in adult patients demonstrated no new safety signals; 17.6 % discontinued due to AEs, that's 28 patients. Sixty-six percent of patients were at a dose of 400 milligrams or greater at week 52. Four hundred twenty-seven was the mean dose of Qelbree, also at week 52.

Let's look at the AISRS total score from this open-label analysis at 12 months. You can see, this is a busy slide, and we can see the phase III trial on the very far left here. Then we can see that 2 weeks where everyone was put back in at 200 milligrams starting and then followed for 52 weeks. You can see this long-term response. I really just want to point out to you at the very end, there's 60% change from baseline in the AISRS total score at 52 weeks.

Getting started with Qelbree. Let's set expectations with our patients when we start Qelbree. Qelbree dosing is flexible. It can be taken in the morning or at night. Qelbree dosing in adults 18 years and older, start at 200 milligrams a day, and you can titrate to 400 and then maximum dose of 600 milligrams over 1 to 2 weeks as needed to reach effective dose. Sixty-six percent of patients were optimized at a dose of 400 milligrams or greater a day.

Qelbree shows no evidence of abuse potential, minimizing risk of treatment abuse, misuse, and diversion. Qelbree can be conveniently prescribed and refilled without a new prescription every month. How freeing is that? A combination of these factors can help patient navigate potential treatment barriers.

The efficacy. Improvements can be seen as early as week 2 in adults. Consider asking about daily activities as they adjust to different internal cues in response to their Qelbree. Like, did you remember your keys more frequently this week? Did you remember where your glasses were, something I miss all the time?

Safety. Discuss the most common side effects patients might experience when taking Qelbree. Utilize the flexible dosing of Qelbree to create a management plan for potential AEs. No drug-drug interactions with amphetamine or methylphenidate.

Let's look at some market dynamics data. Sixty-eight percent of patients were prescribed Qelbree because of a change in from their previous ADHD medication. Thirty-two percent started Qelbree as a new therapy treatment.

The patients who switched to Qelbree came from these pockets: 55% from the stimulant sources and 45% from nonstimulant sources. I don't know about you, but sometimes my patients are not keen on switching from their stimulants.

Let's look at some post hoc data about Qelbree users with prior stimulant experience. It was conducted from the adult phase III trial data. They examined folks who had prior stimulant use and those to no prior stimulant use. And then with the primary objective to evaluate the response to Qelbree based on history of prior stimulant use. And you can see here on this graph to the right, it appears to have been similar. Again, this data is descriptive, and conclusions cannot be drawn, but interesting to note.

Supernus is committed to supporting patients with ADHD and their families. They're the only company providing samples for ADHD. You can order samples online, request from the Supernus representative. It is covered across 75% of commercial lives.

Learn more at QelbreeHCP.com.

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