Treating Adults with ADHD—What Did the Data Show?

Attention-deficit hyperactivity disorder (ADHD) is a very common neurodevelopmental disorder.³ In the United States alone, ADHD is estimated to affect 4.4% of adults.⁴ Adults dealing with ADHD symptoms may suffer from significant impairments in social, academic, and occupational functioning.⁵

Phase III Clinical Trials

A short-term, multicenter, randomized, double-blind, placebo-controlled trial was designed to determine the efficacy of Qelbree (viloxazine extended-release capsules) in treating adults (ages 18-65 years) with ADHD.¹ In this study, Qelbree was given as a flexible-dose monotherapy (n=354). (Figure 1) During the 6-week trial, participants began receiving either placebo or a 200 mg dose of Qelbree once-daily and titrated up to a 400 mg dose once-daily in Week 2.¹ From week 2, the dose was adjusted by 200 mg once-daily to a minimum of 200 mg and a maximum of 600 mg once-daily for the remainder of the trial period.¹ By the end of study (EOS), 8% of patients were taking 200mg/day, 32% were taking 400 mg/day, and 60% were taking 600 mg/day. The average dose at EOS was 504 mg/day.¹

The primary endpoint in this study was the change from baseline (CFB) to the end of study (EOS) on the total score on the ADHD Investigator Symptom Rating Scale (AISRS). AISRS is an 18-item scale evaluating 18 symptoms of ADHD, where higher AISRS scores indicate more severe symptoms.¹ The CFB in the Clinical Global Impression-Severity of Illness (CGI-S) score at EOS was evaluated as a secondary endpoint.^1,2

INDICATION

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

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. 

Treating Adults with ADHD – Study Design^1,2

Figure 1

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. 

Study Results 

The CFB (reduction) in the AISRS Total score showed statistically significant improvement in adults receiving Qelbree compared to those taking placebo at the end of study.¹  (Figures 2, 3 and Table 1)  Likewise, the CFB (reduction) in the CGI-S score was also statistically significant in patients treated with Qelbree compared to patients receiving placebo at the end of study.^1,2 The LS mean change from baseline in AISRS Total Score in the Qelbree treatment group was -15.5, compared to -11.7 observed in the placebo treatment group.

Proven Efficacy in Treating Adults with ADHD at EOS (n=354)²

Inattention and hyperactivity/impulsivity symptom score reductions observed as early as week 2²

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. 

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. 

Safety and Tolerability Results 

The safety of Qelbree was evaluated in adult patients with ADHD, aged 18 to 60 years during a 6-week, randomized, flexible-dose, double-blind, placebo-controlled trial.^1,2 The most common adverse reactions observed in the study were insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation. (Figure 4 and Table 2) These occurred in ≥5% of participants and at least twice the rate seen in placebo patients for any dose.^1,2

Approximately 9% of participants in the adult clinical study discontinued treatment with Qelbree due to an adverse reaction. The most common adverse reactions leading to discontinuation were: fatigue, insomnia, constipation, and headache.^1,2

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. 

Qelbree represents a nonstimulant approach for ADHD in adults 18 years of age and older. In fact, it is the first nonstimulant treatment option approved for adult patients with ADHD in 20 years. As shown in the clinical study discussed here, Qelbree has demonstrated efficacy in treating ADHD and proven safety and tolerability in the phase III adult trial. Furthermore, Qelbree provides a once-daily dosing option with its extended-release capsule formation.

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. 

Please see full Prescribing Information, including Boxed Warning.

Learn more about Qelbree, an extended-release, nonstimulant medication for ADHD: https://www.QelbreeHCP.com/

References

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.
2. Data on file. Supernus Pharmaceuticals, Inc.
3. Nasser A, Faison SL, Liranso T, et al. Evaluation of the effect of SPN-812 (viloxazine extended release) on QTc interval in healthy adults. J Clin Psychiatry. 2020;81(6):20m13395.
4. Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006;163(4):716-723. doi:10.1176/ajp.2006.163.4.716.
5. Tampi RR, Tampi DJ, Elahi M. “Adult Attention-deficit/Hyperactivity Disorder (aADHD).” Psychiatric Times. Available at: https://www.psychiatrictimes.com/view/adult-attention-deficit-hyperactivity-disorder Accessed: April 15, 2022.

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