Qelbree (Viloxazine Extended-Release Capsules) Effectively Treats ADHD in Children and Adolescents 6 to 17 Years of Age

Attention-deficit/hyperactivity disorder (ADHD) occurs commonly in children and adolescents, affecting ~5.4 million youths in the United States alone.³ This neurobehavioral disorder is characterized by age-inappropriate inattentiveness, hyperactivity, and/or impulsivity that affects daily functioning in family, social, and academic areas of life.³ Effectively managing ADHD in youth can involve nonpharmacologic treatments, pharmacologic therapies, or a combination of both.³ Medical professionals choose from the available safe and effective ADHD medications to best care for their patients based on individual need.

Stimulant medications have been a primary course of ADHD treatment prescribed by physicians for decades.³ Prescription nonstimulant medications provide an alternative route to treatment for children and adolescents with ADHD who found stimulant treatment undesirable.³ 

Qelbree is a nonstimulant medication indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.¹

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• Concomitant administration of a monoamine oxidase inhibitor (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 full Important Safety Information to the top left. 

Qelbree Phase III Clinical Trials in Patients 6 to 17 Years of Age¹

Children

Two randomized, double-blind, placebo-controlled trials assessed the efficacy of treating children ages 6 to 11 with once-daily Qelbree (100 mg, 200 mg, or 400 mg) (Figures 1 and 2).^1,3  

All subjects met the following criteria: a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, ADHD diagnosis; an ADHD Rating Scale-5 for Children and Adolescents (ADHD-RS-5) total score ≥ 28 at screening visit; a Clinical Global Impression-Severity score ≥ 4 at screening visit; and remaining ADHD medication-free for at least 1 week prior to randomization.^2,3 All participants were given once-daily Qelbree or placebo for 6 or 8 weeks.^2,3 Change from baseline (CFB) at the end of study (EOS) in the ADHD-RS-5 total score was the primary endpoint observed.^2,3 Additional changes in Clinical Global Impression-Improvement (CGI-I) score at EOS as well as CFB at EOS in the Conners 3-Parent Composite T-Score (Conners 3-PS) and the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P) total average score were noted as secondary endpoints.^2,3 Laboratory tests, vital signs, physical examinations, electrocardiograms, and adverse events were monitored for safety considerations.³

Clinical Trial Protocol: P301 Study Design^1,2

IMPORTANT SAFETY INFORMATION

• Suicidal thoughts and behaviors: Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes

Please see full Important Safety Information to the top left. 

Clinical Trial Protocol: P303 Study Design^1,2

IMPORTANT SAFETY INFORMATION

• Heart rate, blood pressure increases: Qelbree can cause an increase in diastolic blood pressure and heart rate. Assess these measures prior to starting therapy, following increases in dosage, and periodically during therapy

Please see full Important Safety Information to the top left. 

Adolescents

A randomized, placebo-controlled clinical trial evaluated the efficacy of once-daily Qelbree (200 mg-400 mg) in treating ADHD in adolescents ages 12 to 17 years.^1,4 Study subjects were given once-daily Qelbree or placebo for 6 weeks (Figure 3).^2,4 The primary endpoint under consideration was the CFB in the ADHD-RS-5 total score at EOS. Additional changes were measured in the CGI-I score at EOS, CFB at EOS in the Conners 3-PS Composite T-score, and CFB at EOS in the WFIRS-P total average score as secondary endpoints.^2,4

Clinical Trial Protocol: P302 Study Design^1,2

IMPORTANT SAFETY INFORMATION

• Activation of mania or hypomania: Noradrenergic drugs may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment with Qelbree, screen patients to determine if they are at risk for bipolar disorder. Screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression

Please see full Important Safety Information to the top left. 

Study Results

Children

Qelbree met the primary endpoint (change from baseline in the ADHD-RS-5 total score at EOS).^1,2 Both Qelbree treatment groups (100 mg and 200 mg) showed statistically significant improvements in ADHD-RS-5 total scores compared to the placebo group as early as week 1 of treatment.^1,2 The CFB in ADHD-RS-5 total score at EOS (LS mean ± SE) was -16.6 ± 1.16 for Qelbree 100 mg/day, -17.7 ± 1.12 for Qelbree 200 mg/day, and -10.9 ± 1.14 for placebo.³ This effect was maintained until EOS (Figures 4 and 5).³ Additionally, significant improvements were seen at EOS in the CGI-I scale compared to the placebo group.^2,3

IMPORTANT SAFETY INFORMATION

• Somnolence and fatigue: Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, due to potential somnolence (including sedation or lethargy) and fatigue, until they know how they will be affected by Qelbree

Please see full Important Safety Information to the top left. 

IMPORTANT SAFETY INFORMATION

• 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.

Please see full Important Safety Information to the top left. 

Adolescents

Qelbree met the primary endpoint (change from baseline in the ADHD-RS-5 total score at EOS).⁴ Statistically significant improvements were observed in both Qelbree treatment groups (200 mg/d and 400 mg/d) in the CFB at EOS in the ADHD-RS-5 total and the Inattention and Hyperactivity/Impulsivity subscale scores compared to placebo. The CFB in ADHD-RS-5 total score at EOS (LS mean ± SE) was -16.0 ± 1.45 for Qelbree 200 mg/day, -16.5 ± 1.38 for Qelbree 400 mg/day, and -11.4 ± 1.37 for placebo.³ This effect was maintained until EOS (Figures 6 and 7).⁴ The changes in CGI-I scores were also statistically significant at EOS in both treatment groups compared to placebo.⁴ 

IMPORTANT SAFETY INFORMATION

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Qelbree during pregnancy. Health care providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or by visiting www.womensmentalhealth.org/preg.

Please see full Important Safety Information to the top left. 

IMPORTANT SAFETY INFORMATION

• Suicidal thoughts and behaviors: Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes

Please see full Important Safety Information to the top left. 

Safety and Tolerability Results in Patients 6 to 17 Years of Age¹

The most common adverse events in patients 6 to 17 years of age (occurring in ≥5% of subjects and twice the rate of placebo for any dose) were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability (Figure 8). The discontinuation rates for either age group due to these adverse events were low, at 3% for Qelbree and 1% for placebo.¹

References

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.
2. Data on file. Supernus Pharmaceuticals, Inc.
3. Nasser A, Liranso T, Adewole T, et al. A phase III, randomized, placebo-controlled trial to assess the efficacy and safety of once-daily SPN-812 (viloxazine extended-release) in the treatment of attention-deficit/hyperactivity disorder in school-age children. Clin Ther. 2020;42(8):1452-1466. doi:10.1016/j.clinthera.2020.05.021
4. Nasser A, Liranso T, Adewole T, et al. A phase 3, placebo-controlled trial of once-daily viloxazine extended-release capsules in adolescents with attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2021;41(4):370-380. doi:10.1097/JCP.0000000000001404

QBE.2022-0268