A Peer-to-Peer Conversation Between Dr. Andrew Cutler and Dr. Gregory Mattingly on an Approved Treatment Option for ADHD

QBE.2022-0271

In this video, watch Dr. Andrew Cutler and Dr. Gregory Mattingly engage in a conversation about a nonstimulant medication for ADHD in patients 6 years and older. These 2 healthcare practitioners share exciting findings from the pivotal clinical trials conducted in children, adolescents, and adults.

Read the full transcript:

Andrew Cutler: ADHD is a chronic mental illness that in many patients requires lifelong treatment.

We know from a very important recent study by Dr. Maggie Sibley and colleagues that was published this past February in the American Journal of Psychiatry that up to 90% of patients diagnosed with ADHD in childhood continue to have symptoms in adulthood.

Andrew Cutler: Now, these patients can manage their ADHD symptoms with either medication or a combination of both medication and psychosocial treatments.

Greg, how would you describe the current treatment landscape for ADHD? Do you notice any unmet patient needs?

Gregory Mattingly: Certainly. So currently, the treatment primarily focuses on pharmacotherapy with stimulant medications.

Although these medications can be very effective, providers are always looking for nonstimulant options for their patients with ADHD.

Gregory Mattingly: In addition, ADHD in adults often goes untreated and is associated with impairments across multiple life domains, including what's happening at home, what's happening at school, what's happening at work, your social interactions. It's not just limited to the typical 8-hour workday.

These challenges are particularly noticeable in the late afternoon and evening hours when medications wear off and symptoms can recur.

Gregory Mattingly: The availability of a long-acting, safe, and effective medication could represent a treatment option for our patients with ADHD and lead to symptom control for our patients.

Gregory Mattingly: Speaking of nonstimulant medications, Andy, do you, as a provider, experience situations in which a nonstimulant medication would be helpful for your patients?

Andrew Cutler: Boy, Greg, I sure do, and there are many different situations where a nonstimulant option rises to the top of my list.

Andrew Cutler: First of all, there are many situations when either a patient or caregiver will say “I don't want to take a stimulant,” or “Whatever you do, don't give me a stimulant.”

Andrew Cutler: Some patients may not respond to stimulant medications, although they do work for a majority of patients. Many patients don't tolerate stimulant medications due to the side effects.

Andrew Cutler: They may be contraindicated in patients who perhaps have a history of substance abuse or a very strong family history of substance abuse, or someone who has someone with a substance abuse problem living in their house, or sometimes someone who is living in a situation where they can't keep control of their medications, such as a college student.

In all of those situations, I find a nonstimulant option to be extremely valuable.

Andrew Cutler: So now, let's talk about nonstimulant medications available to treat ADHD such as Qelbree. Greg, what do we know about Qelbree and what it offers to patients struggling with ADHD?

Gregory Mattingly: Qelbree, or viloxazine extended-release capsules, is a nonstimulant, nonscheduled medication that is approved by the US Food and Drug Administration to treat ADHD in pediatric patients age of 6 and older, but also in our adult patients struggling with ADHD.

Qelbree does have a boxed warning about suicidal ideation.

Gregory Mattingly: Additionally, Qelbree is the first nonstimulant therapy to be approved for adults with ADHD in 2 decades and the second nonstimulant ever to be approved in the treatment of our adult patients with ADHD.

Gregory Mattingly: Andy, as a clinician, when can our patients start to see a response from treatment with Qelbree?

Andrew Cutler: Well, Greg, this is a very important question that we get asked all the time, and I like to go to the clinical data.

Andrew Cutler: So, first of all, in the clinical trials of pediatrics of children ages 6 to 11, efficacy was seen for inattention and hyperactivity/impulsivity symptoms as early as week 1.

Andrew Cutler: In the adolescents ages 12 to 17 and the adults, they saw symptom score reductions as early as week 2.

Andrew Cutler: Greg, it’s always important to know what possible side effects you might see. So, what are the most common adverse events that patient should look out for?

Gregory Mattingly: The most commonly observed adverse reactions were, for our pediatric patients aged 6 to 17 years of age: somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.

In our adult patients: insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation.

Gregory Mattingly: Andy, what should health care providers know about using Qelbree with other medications?

Andrew Cutler: Well, there are a few things that you should be aware of, and they are well described in the prescribing information. First of all, Qelbree was studied in a single-dose study in adults co-administered with either an amphetamine or methylphenidate and, importantly, no pharmacokinetic interactions were seen between Qelbree or either the amphetamine or the methylphenidate.

Andrew Cutler: It’s important to realize that Qelbree is metabolized by cytochrome p4502D6 (CYP2D6). So, we would have concerns about what other medications might do to the metabolism of Qelbree. It turns out that no dose adjustments are required with concomitant use of CYP2D6 inhibitor– -- for instance, paroxetine, which was studied. Likewise, no dose adjustments are required in CYP2D6 poor metabolizers

Andrew Cutler: Now, what about Qelbree’s effects on other medications? Well, Qelbree is a strong inhibitor of CYP1A2. So concomitant use of viloxazine increases the total exposure, but not the peak exposure, or C Max, of drugs metabolized predominantly by the CYP1A2 pathway. So, this might increase the risk of adverse reactions and especially the duration of adverse reactions associated with these drugs.

Qelbree is therefore contraindicated with concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range.

Andrew Cutler: Qelbree itself is also a weak inhibitor of CYP2D6 and CYP3A4.

Andrew Cutler: Now, there’s no contraindications around this, but it is advisable for you to monitor patients taking concomitant medications that are metabolized by 3A4 or 2D6 and look for any adverse reactions and consider lowering the doses of those drugs as clinically indicated.

Andrew Cutler: Well, now let’s talk about dosing. Greg, what should health care providers and their patients know about Qelbree in terms of dosing?

Gregory Mattingly: First of all, Qelbree comes in 3 capsule strengths: a 100-milligram, a 150-milligram, and a 200-milligram capsule.

Gregory Mattingly: If we look at each of these capsules, the 100-milligram capsule has its own specific color and is stamped right on the outside of the capsule.

The 150-milligram capsule is a separate color, and once again, is stamped on the outside. And, finally, the 200-milligram strength dose.

Gregory Mattingly: Qelbree offers once-daily doses, so taking it once a day provides full-day exposure. Qelbree can also be taken either with or without food.

Gregory Mattingly: In addition, Qelbree capsules can be taken whole, or the entire contents can be sprinkled over a spoonful of pudding or applesauce.

Gregory Mattingly: For children ages 6 to 11, start with Qelbree 100 milligrams and titrate weekly over the next 1 to 3 weeks, as needed, to reach an effective dose, with the maximum dose for children being 400 milligrams per day.

Gregory Mattingly: For adolescents aged 12 to 17, start with 200 milligrams and titrate Qelbree weekly, as needed, to reach an effective dose. The maximum dose for adolescents is also 400 milligrams.

Gregory Mattingly: Finally, for our adults aged 18 and older, start with Qelbree 200 milligrams per day and titrate once weekly over the next 1 to 2 weeks to reach the effective dose, with the maximum daily dose for adults being up to 600 milligrams per day.

Gregory Mattingly: In clinical trials, an important finding was there was no clinically significant elevation of liver function tests or enzymes, as reported in patients receiving Qelbree. No dosage adjustment is necessary in your patients with hepatic impairment.

Gregory Mattingly: Andy, is there any risk of diversion or abuse with Qelbree in patients with ADHD?

Andrew Cutler: Well, that's a very important question, because, as we know, the stimulant medications certainly are associated with those risks.

Qelbree is a nonscheduled, nonstimulant medication and has showed no evidence of abuse potential in the clinical trials, and we don't see a risk, therefore, of abuse, misuse, or diversion.

Andrew Cutler: Also, viloxazine, which is the active ingredient in Qelbree—Qelbree is viloxazine extended-release capsules, as you know-- viloxazine was found to be free of any physical drug dependence in animal models of abuse liability.

Andrew Cutler: And finally, there were no reports of withdrawal symptoms or signs of dependence reported as adverse events during human clinical trials, so my answer, Greg, is there really does not seem to be a risk for abuse, diversion, or misuse.

Andrew Cutler: Finally, Greg, is there anything else you'd like to share with health care providers regarding Qelbree as a treatment option for their ADHD patients?

Gregory Mattingly: Well, Andy, there’s a lot of things that come to mind. But first of all, this is a medicine that can be sampled.

Gregory Mattingly: We have sample kits for the children. They start at 100 milligrams and work their way up. We have sample kits for the adolescents to start at 200 milligrams. And, we have sample kits specifically designed for your adult patients with ADHD.

Gregory Mattingly: …It's also important to remember that, as a nonscheduled product, refills can be written for our patients.

Gregory Mattingly: So, once we find the appropriate dose, we can go ahead and write for refills. We can write for 90 days if that's an appropriate thing with your patient.

Gregory Mattingly: In addition, if you'd like extra resources, I’d like to refer you to www.QelbreeHCP.com. Educational resources for your practice, for your patients, for further education and knowledge about what is ADHD and how does it affect myself and my family.