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Proven efficacy

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

Teens 12 to 17 years of age

Teens 12 to 17 years of age

Inattention and hyperactivity/impulsivity symptom score reductions observed as early as week 2.2

Qelbree was studied in 4 clinical trials. In the study of teens 12 to 17 years of age, ADHD symptom score reductions were statistically significant for 400 mg, beginning at week 2.3

Qelbree is the first novel, non-stimulant treatment approved for pediatric ADHD in over a decade1,4-6

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

Phase III trial methodology1

The clinical trial was a randomized, double-blind, placebo-controlled, 3-arm, parallel-group, multicenter study.

Primary endpoint1

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

Primary analysis is based on mITT population.1,2

Study P302 EOS=Week 6.1

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 P302: Titration at 1 week1,7

Age group: 12 to 17 years of age
mITT population: 301
Study medication: 200 mg capsule or matching placebo

Proven efficacy in a robust clinical trial1

 

Primary efficacy measure: CFB to EOS on the ADHD-RS-5 Total Score vs placebo (n=301)1,2

Study P302 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 -16.0 ± 1.45 for Qelbree 200 mg/day, -16.5 ± 1.38 for Qelbree 400 mg/day, and -11.4 ± 1.37 for placebo.

  • Once-daily Qelbree delivers significant symptom score reductions on the subscales of both inattention and hyperactivity/impulsivity in teens3
  • Once-daily Qelbree demonstrates proven safety and tolerability and low discontinuation rates due to AEs in children and teens across clinical trials1,2

Abbreviations: ADHD-RS-5, Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th ed; CFB, change from baseline; EOS, end of study; LS mean, least squares mean; SE, standard error.

Long-term safety and efficacy trial of Qelbree in children and teens ages 6-17 years with ADHD3

 

OLE study (P310): Subpopulation analysis, Qelbree 100 mg/day to 400 mg/day3†

Methodology1,3

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 400mg/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 objective3

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 teens following 24 months in treatment in the OLE study

Teens (n=34)

Total daily dose of Qelbree in teens following 24 months of treatment in the OLE study3

Following 24 months of treatment with once-daily Qelbree3:

  • 100 mg/day was the least prevalent dose for teens
  • Approximately 65% of teens were taking Qelbree 300 to 400 mg/day

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

Long-term data: ADHD-RS-5 Total Score in the OLE subpopulation analysis3

 

Mean change from baseline in ADHD-RS-5 Total Score3‡

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 conclusions3
  • 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/day3

Qelbree pediatric OLE subpopulation safety analysis3:

  • 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.3

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

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Qelbree dosing Efficacy in adults over 18 

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 3, placebo-controlled trial of once-daily viloxazine extended-release capsules in adolescents with attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2021;41(8):370-372, 374-376. 3. Data on file, Supernus Pharmaceuticals. 4. INTUNIV [package insert]. Wayne, PA: Shire US, Inc. 5. US Food and Drug Administration. Summary review, NDA approval 22-037. September 2, 2009. Accessed October 21, 2021. 6. 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. 7. Nasser A, Kosheleff A, Hull J, et al. Translating attention-deficit/hyperactivity disorder rating scale-5 and Weiss functional impairment rating scale-parent effectiveness scores into clinical global impressions clinical significance levels in four randomized clinical trials of SPN-812 (viloxazine extended-release) in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2021;31(2):215-216,223.

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.