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Proven efficacy

Significant reduction in ADHD-RS-5 total score from CFB to EOS (6 weeks)1

Children 6 to 11 years of age

Inattention and hyperactivity/impulsivity symptom score reductions observed as early as week 1.2,3

Qelbree was studied in 4 clinical trials. In one study of children 6 to 11 years of age, ADHD symptom score reductions were statistically significant for 100 mg and 200 mg dose, beginning at week 1.4

Qelbree is the first novel, non-stimulant treatment approved for pediatric ADHD in over a decade1,5-7

Efficacy_Children_Small

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

Phase III trials methodology1

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

Primary endpoint1

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

Primary analysis is based on mITT population.2,3

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; DSM-5, Diagnostic and Statistical Manual of Mental Disorders. 5th ed; EOS, end of study; mITT, modified intent to treat.

Simple to start1

 

Study P301: Titration at 1 week2

Age group: 6 to 11 years of age
mITT population: 460
Study medication: 100 mg capsule or matching placebo

Proven efficacy in robust clinical trials2

 

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 significant symptom score reductions on the subscales of both inattention and hyperactivity/impulsivity in children
  • Once-daily Qelbree demonstrates proven safety and tolerability and low discontinuation rates due to AEs in children and teens across clinical trials1,2
Efficacy_Children_Interior_Small

Efficacy established in children (6 to 11 years) in randomized, placebo-controlled trials1

 

Study P303: Titration through 3 weeks3

Age group: 6 to 11 years of age
mITT population: 301
Study medication: 100 mg capsule or matching placebo

Study P303 Results:

Proven efficacy in treating ADHD (N=301). 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.3

Long-term safety and efficacy trial of Qelbree in children and teens ages 6-17 years with ADHD4

 

OLE study (P310): Subpopulation analysis, Qelbree 100 mg/day to 400 mg/day4†

Methodology1,4

Open-label, long-term, multicenter, flexible-dose study of Qelbree in children with ADHD who completed a phase II/III trial of Qelbree 100 mg/day to 400 mg/day. Patients aged 6 to 11 years began with Qelbree 100 mg/day, adjusted weekly by 100 mg increments based on clinical response (100 mg/day to 400 mg/day). Patients aged 12 to 17 years began with Qelbree 200 mg/day, adjusted weekly by 200 mg increments based on clinical response (200 mg/day to 400 mg/day).†

The number of patients at each time point was as follows: entering OLE (n=749), completing optimization period (n=672), month 3 (n=594), month 6 (n=492), month 9 (n=397), month 12 (n=337), and month 24 (n=200). The data presented here include patients who completed visits up to 24 months.

Primary objective4

Gather long-term safety data on Qelbree.

Secondary objective1

Efficacy data during open-label use.

A pie chart showing the total daily dose of Qelbree® in children following 24 months in treatment in the OLE study

Children (n=148)

Total daily dose of Qelbree in children following 24 months of treatment in the OLE study4

Following 24 months of treatment with once-daily Qelbree4:

  • 100 mg/day was the least prevalent dose for children
  • Nearly 70% of children were taking Qelbree 300 to 400 mg/day

†Dose will depend on response to medication. Maximum dose of Qelbree in children is 400 mg/day.

Long-term data: ADHD-RS-5 Total Score in the OLE subpopulation analysis4

 

Mean change from baseline in ADHD-RS-5 Total Score4‡

P310 (OLE): Overall baseline ADHD-RS-5 Total Score was 42.9 for Qelbree

  • Data and calculations from patients in the OLE are descriptive only. There is no placebo group from which to draw a comparison of changes from baseline in ADHD-RS-5 Total Score or make any other long-term safety or efficacy conclusions4
  • OLE start: patients 6 to 11 years of age started on Qelbree 100 mg/day; patients 12 to 17 years of age started on Qelbree 200 mg/day4

Qelbree pediatric OLE subpopulation safety analysis4:

  • No new safety signals observed for Qelbree 100 mg/day to 400 mg/day
  • 8.1% discontinuation rate due to AEs

See pediatric phase III safety profile

‡Based on 3 randomized, double-blind, placebo-controlled, parallel-group clinical trials that met the primary endpoint of data in ADHD-RS-5 total symptom score.4

Abbreviations: AEs, adverse events; LS mean, least squares mean; OLE, open-label extension; SE, standard error.

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Efficacy in teens12-17 Qelbree dosing 

IMPORTANT SAFETY INFORMATION

INDICATION

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

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

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

 

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

  • 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
  • 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) 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. 

PREGNANCY

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Qelbree during pregnancy. Healthcare 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 Prescribing Information, including Boxed Warning.

References:

1. Qelbree. Prescribing information. Supernus Pharmaceuticals Inc; 2022. 2. 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;(8):1452-1466. 3. Nasser A, Liranso T, Adewole T, et al. Once-daily SPN-812 200 and 400 mg in the treatment of ADHD in school-aged children: a phase III randomized, controlled trial. Clin Ther. 2021;43(4):684-700. 4. Data on file, Supernus Pharmaceuticals. 5. INTUNIV [package insert]. Wayne, PA: Shire US, Inc. 6. US Food and Drug Administration. Summary review, NDA approval 22-037. September 2, 2021. Accessed October 21, 2021. 7. Food and Drug Administration. Novel drug approvals for 2021. May 13, 2022. Accessed January 7, 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021.

IMPORTANT SAFETY INFORMATION

INDICATION

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

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

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

 

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

  • 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
  • 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) 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. 

PREGNANCY

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Qelbree during pregnancy. Healthcare 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 Prescribing Information, including Boxed Warning.