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Dr. Birgit Amann and Dr. Frank Lopez Share Their Thoughts on Management of ADHD in Adults and Children 6 Years and Older

03/29/2023

 

QBE.2022-0361

In this video, Dr. Birgit Amann and Dr. Frank Lopez dicsuss their enthusiasm about a nonstimulant treatment for Attention-Deficit/Hyperactivity Disorder in adults and children 6 years and older in clinical practice and clinical studies.

Read the full transcript:

Dr. Amann: Hi, everyone. My name is Birgit Amann, and joining me today is my colleague, Frank Lopez. We are consultants who have been compensated by Supernus Pharmaceuticals. We welcome you to our video where we will be discussing management of Attention- Deficit/Hyperactivity Disorder, or ADHD, and how it differs between pediatric patients ages 6 to 17 years versus adult patients 18 years and older. Thanks for joining me for this conversation, Dr. Lopez.

Dr. Lopez: Happy to be here.

Dr. Amann: So, Frank, from your clinical experience, what are the most problematic daily challenges for pediatric patients with ADHD for which parents seek treatment?

Dr. Lopez: Well, that’s a great question, Birgit. In my clinical experience, many patients have difficulty with tasks in their everyday life such as staying focused in school, organization, and trouble maintaining relationships with their peers. Typically, teachers or schools prompt parents to seek evaluation and potentially treatment for their children between the ages of 6 to 11 years of age. When seeking an evaluation, schools and family can be sought out for any concerns the patient is experiencing.

So, after hearing that, how would you say the daily challenges of adults with ADHD in your practice compare with those in pediatric patients?

Dr. Amann: As you mentioned Frank, adults ages 18 years and older, like children ages 6 to 17 years, also face several challenges when seeking treatment for ADHD. ADHD impacts many facets of an adult's life, from academic underachievement and problems in work performance to personal relationship issues. These everyday challenges may be made worse by untreated or undiagnosed adult ADHD.

Speaking of treatment, Frank, how do you talk about ADHD treatments with your patients?

Dr. Lopez: Well Birgit, information is an important tool in the treatment of ADHD. I talk to my patients and their parents about the two types of ADHD drugs, stimulants and nonstimulants, and share the risks and benefits of using each type of medication.

Educational literature about ADHD should be handed out to patients and caregivers, and arrangements should be made for supportive, cognitive, behavioral, and interpersonal psychotherapy.

Dr. Amann: Exactly, I work with my adult patients to find the right treatment for each unique patient and check to make sure they do not have any contraindications or possible drug interactions.

So, what important aspects of treatment do you consider when treating pediatric patients compared to adult patients?

Dr. Lopez: I can certainly think of a few things that are particularly beneficial to younger patients.

First, being able to sprinkle the medication is a welcome option as there are children and occasionally adolescents who have difficulty swallowing capsules, so having the ability to sprinkle is a benefit.

Secondly, there is a potential risk of stimulant diversion in all age ranges, and parents are often hesitant to give stimulants to them, so it is valuable to have nonstimulant options available.

Finally, a medication that offers full-day exposure would be beneficial.

Do you consider having a nonstimulant option for ADHD management in adults ages 18 years and older as well as for children and adolescents ages 6 to 17 years to be valuable? 

Dr. Amann: Definitely. There are several cases in which adult patients don’t respond adequately to stimulant medications, so it is important to have nonstimulant options.

In fact, as many as 20-35% of subjects in clinical trials may have inadequate responses to initial stimulant treatment. For patients who do not respond to or cannot tolerate stimulants, one option is to try nonstimulant medications.

And now we do have another nonstimulant ADHD medication approved not only for children ages 6 to 17 years, but also for adults 18 years and older: Qelbree (viloxazine extended-release capsules).

Voiceover: Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 years and older.

Voiceover: 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.

Voiceover: Patients should not take Qelbree with or within 14 days of taking a monoamine oxidase inhibitor (MAOI), because of an increased risk of hypertensive crisis. Patients should not take Qelbree with sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range.

Dr. Amann: Qelbree offers potential solutions to several of the issues we’ve discussed here. For one, Qelbree can be sprinkled for our patients who struggle to swallow pills. The extended-release formulation provides full-day exposure.

And again, it’s a nonstimulant, so there is no concern of abuse as evidenced in clinical studies. Before, if a child or an adult patient couldn't swallow a pill or capsule but were a better candidate for a nonstimulant, they had no option. Having the ability with Qelbree to sprinkle the capsule is highly beneficial to these patients. It finally allows a nonstimulant to be a viable option for them, which is incredibly significant.

Dr. Amann: Additionally, in the pediatric and adolescent clinical studies, which was ages 6 to 17 years, Qelbree met the primary endpoint of a statistically significant improvement in change from baseline of the ADHD Rating Scale, 5th Edition (ADHD-RS- 5) Total Score at the end of the study compared with placebo. In the adult studies, Qelbree met the primary endpoint of a statistically significant improvement in change from baseline of the Adult ADHD Investigator Symptom Rating Scale or AISRS Total Score at the end of the study compared with placebo.

Dr. Amann: Furthermore, Inattention and Hyperactivity/Impulsivity symptom score reductions were observed early in treatment. This is a definite positive aspect of Qelbree. My patients have tolerated it very well and successfully utilized it. However, it is important to be aware of the potential side effects and precautions. The most common adverse reactions (≥5% and at least twice the rate of placebo for any dose) in patients 6 to 17 years were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability, and in adults, insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation.

Dr. Amann: There are several dosing options available with Qelbree based on age and tolerability. For pediatric patients 6 to 11 years of age, the recommended starting dose is 100 mg once daily. One week after initiating treatment, the dose can be titrated up by 100 mg increments per week to a maximum dose of 400 mg once daily, based on treatment response and tolerability. For adolescent patients 12 to 17 years of age, the recommended starting dose is 200 mg once daily. One week after initiating treatment, the dose can be titrated up by a 200 mg increment to a maximum dose of 400 mg once daily, based on treatment response and tolerability. For adult patients, the recommended starting dose is 200 mg once daily. One week after initiating treatment, the dose can be titrated up by 200 mg increments per week to maximum dose of 600 mg once daily, based on treatment response and tolerability.

Overall, what is your experience with prescribing Qelbree, Frank? Have you experienced similarities between your clinical practice, experience, and the results of the clinical trials?

Dr. Lopez:  In our clinical practice we have seen many benefits. Still, the most salient have been the longer duration, allowing for better coverage of the patient’s needs throughout the day and the efficacy in treating ADHD. On the one hand, seeing improvements in clinical trials is excellent, but seeing children and adolescents, ages 6 to 17 years, improve consistently in clinical practice it's terrific. As a reminder Qelbree is administered once daily. How about you, Birgit? In your experience with prescribing Qelbree, what have you observed regarding the management of ADHD in your clinical practice patients and the results of the clinical trials?

Dr. Amann: Thus far, it's been as expected based on the clinical trials. I spend a great deal of time with patients and parents, educating them about Qelbree. What to expect, what not to expect, the most common side effects and precautions, the dosing. To date, I have not witnessed any significant differences between my patients’ experiences and the results of the clinical trials. It's been a very welcome addition to the nonstimulant medication class! Thank you, Frank, for joining me today.

Dr. Lopez: Birgit, thank you. Thanks to all of the folks in the audience for participating and I hope that the information we have shared regarding Qelbree, the Viloxazine extended-release capsules for the treatment of children 6 years of age and older and adults, 18 years of age and older, is helpful for the treatment and management of ADHD. Thanks again, Birgit.

Dr. Amann: Again, thanks to all of you for joining us.

QBE.2022-0361