Icon: Graph showing improvement

Proven efficacy

Significant reduction in ADHD-RS-5 total score from CFB to EOS1,2

Children 6 to 11 years of age

Qelbree showed improvement in symptoms of inattention, hyperactivity, and impulsivity consistently as early as week 1.1,2

 

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Qelbree delivers a significant improvement on the subscales of both inattention and hyperactivity/impulsivity.1

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ADHD diagnosis based on ADHD-RS-5 screener and DSM-5 criteria

Phase III trials methodology1,2

All clinical trials were randomized, double-blind, placebo-controlled, 3-arm, parallel-group, multicenter studies.

Primary endpoint

CFB in the ADHD-RS-5 total score at EOS, Qelbree treatment group.

Inclusion criteria to include: males and females; children 6 to 11 years; ADHD diagnosis based on criteria in the DSM-5, confirmed with the MINI-KID; ADHD-RS-5 total score of ≥28; CGI-S ≥4.

Exclusion criteria to include: major psychiatric disorder (MDD history allowed); major neurobiological disorder; history of seizures; significant systemic disease; evidence of suicidality within prior 6 months before screening.

Secondary analysis is based on ITT population.2

Study P301 EOS=Week 6; Study P303 EOS=Week 8.1

Abbreviations: ADHD-RS-5, Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th ed; CFB, change from baseline; CGI-S, Clinical Global Impression–Severity of Illness; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, 5th ed; EOS, end of study; ITT, intention to treat; MDD, major depressive disorder; MINI-KID, Mini-International Neuropsychiatric Interview for Children and Adolescents.

Simple to start1,2

 

Study P301: Titration at 1 week1,2

Age group: 6 to 11 years of age
ITT population: N=460
Study medication: 100-mg or matching placebo

Proven efficacy in robust clinical trials1,2

 

Primary efficacy measure: CFB to EOS on the ADHD-RS-5 Total Score vs placebo (N=460)1,2

Study P301 Results:

Total score at EOS was significantly reduced with Qelbree vs placebo. 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.2

  • Once-daily Qelbree delivers a significant improvement on the subscales of both inattention and hyperactivity/impulsivity in children and adolescents.2
  • Once-daily Qelbree demonstrates proven safety and tolerability and low discontinuation rates due to AEs in children and adolescents.1,2
Efficacy 2 Small

Efficacy established in children (6 to 11 years) in 2 randomized, placebo-controlled trials.2

 

Study P303: Titration through 3 weeks1,2

Age group: 6 to 11 years of age
ITT population: N=301
Study medication: 100-mg or matching placebo

Study P303 Results:

Proven efficacy in treating ADHD (n=301).1,3 Total score at EOS was significantly reduced with Qelbree vs placebo. The CFB in the ADHD-RS-5 total score (LS mean ± SE) was -17.6 ± 1.43 for Qelbree 200 mg/day, -17.5 ± 1.52 for Qelbree 400 mg/day, and -11.7 ± 1.48 for placebo.2

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IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric patients ages 6 to 17.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in pediatric [read more] 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.

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in pediatric patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all [read more]Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

IMPORTANT SAFETY INFORMATION (CONT’D)

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

WARNINGS & PRECAUTIONS

  • 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
  • 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
  • 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

ADVERSE REACTIONS

The most common adverse reactions (≥ 5% and at least twice the rate of placebo for any dose) were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.

DOSING SAFETY INFORMATION

  • Swallow Qelbree capsules whole or sprinkle entire contents on a teaspoonful of applesauce and consume all within 2 hours, without regard to meals. Do not cut, crush, or chew the capsules
  • Severe renal impairment: Initiate Qelbree at 100 mg once daily and increase by 50 mg to 100 mg at weekly intervals to a maximum recommended dosage of 200 mg once daily
  • Prior to initiating treatment, following increases in dosage, and periodically during therapy, measure heart rate and blood pressure
  • Qelbree is a strong CYP1A2 inhibitor. Coadministration with moderately sensitive CYP1A2 substrates (eg, clozapine and pirfenidone) is not recommended. If coadministered, dose reduction may be warranted
  • Qelbree is a weak inhibitor of CYP2D6 and CYP3A4, which increases exposure of those substrates (eg, dextromethorphan and alfentanil) when coadministered with Qelbree. Monitor patients for adverse reactions and adjust dosages of substrates as clinically indicated
    • For a more complete list of drug-to-drug interactions, including clinical effects and examples, please see table 2 in section 7 of the full Prescribing Information

PREGNANCY & LACTATION

  • Qelbree may cause maternal harm. It is not known if Qelbree passes into breastmilk or if Qelbree has an effect on the breastfed infant. Discontinue Qelbree if the risks of therapy during pregnancy outweigh the benefits

Please see full Prescribing Information, including Boxed Warning.

References:

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc;
2. Data on file, Supernus Pharmaceuticals.

IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric patients ages 6 to 17.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in pediatric [read more] 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.

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in pediatric patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all [read more]Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

IMPORTANT SAFETY INFORMATION (CONT’D)

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

WARNINGS & PRECAUTIONS

  • 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
  • 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
  • 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

ADVERSE REACTIONS

The most common adverse reactions (≥ 5% and at least twice the rate of placebo for any dose) were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.

DOSING SAFETY INFORMATION

  • Swallow Qelbree capsules whole or sprinkle entire contents on a teaspoonful of applesauce and consume all within 2 hours, without regard to meals. Do not cut, crush, or chew the capsules
  • Severe renal impairment: Initiate Qelbree at 100 mg once daily and increase by 50 mg to 100 mg at weekly intervals to a maximum recommended dosage of 200 mg once daily
  • Prior to initiating treatment, following increases in dosage, and periodically during therapy, measure heart rate and blood pressure
  • Qelbree is a strong CYP1A2 inhibitor. Coadministration with moderately sensitive CYP1A2 substrates (eg, clozapine and pirfenidone) is not recommended. If coadministered, dose reduction may be warranted
  • Qelbree is a weak inhibitor of CYP2D6 and CYP3A4, which increases exposure of those substrates (eg, dextromethorphan and alfentanil) when coadministered with Qelbree. Monitor patients for adverse reactions and adjust dosages of substrates as clinically indicated
    • For a more complete list of drug-to-drug interactions, including clinical effects and examples, please see table 2 in section 7 of the full Prescribing Information

PREGNANCY & LACTATION

  • Qelbree may cause maternal harm. It is not known if Qelbree passes into breastmilk or if Qelbree has an effect on the breastfed infant. Discontinue Qelbree if the risks of therapy during pregnancy outweigh the benefits

Please see full Prescribing Information, including Boxed Warning.