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Proven efficacy

Significant reduction in AISRS total score from CFB to EOS (6 weeks)1

Adults 18 years and older

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

Qelbree was studied in 4 clinical trials. In the flexible-dose study of adults 18 to 65 years of age, ADHD symptom score reductions were statistically significant in patients taking Qelbree, beginning at week 2.2

Qelbree is the first novel, non-stimulant treatment approved for adult ADHD in over 20 years1,3,4

Post Hoc Data

Phase III trial methodology1

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

Primary endpoint1

CFB to EOS in AISRS total score, Qelbree treatment group.

Study P306 EOS=6 weeks.1

Abbreviations: AISRS, ADHD Investigator Symptom Rating Scale; CFB, change from baseline; EOS, end of study.

Simple to start

 

Study P3061

Age group: Adults, 18 to 65 years of age 
mITT population: 354 
Study medication: Flexible dosing (200 mg to 600 mg) or matching placebo

No study visit was scheduled/performed at week 51,2

Post Hoc Data

Proven efficacy in a robust clinical trial1

 

Primary efficacy measure: CFB to EOS in AISRS total score vs placebo (N=354)1,2

Qelbree Flexible Dosing Results:

Patients were titrated to receive 200 mg/day for week 1; 400 mg/day for week 2; and from week 3 to EOS, the investigators could titrate up or down by 200 mg/day each week up to 600 mg/day.2

A pie chart showing the percentage of patients treated by dose at EOS

Percentage of patients treated by dose at EOS (n=133)2

Study P306 results:

AISRS Total Score at EOS was significantly reduced in adults treated with Qelbree vs placebo. The CFB in AISRS Total Score at EOS (LS mean ± SE) was -15.5 ± 0.91 for Qelbree and -11.7 ± 0.90 for placebo.1

  • Once-daily Qelbree delivers significant symptom score reductions on the subscales of both inattention and hyperactivity/impulsivity in adults2
  • Once-daily Qelbree demonstrates proven safety and tolerability with no evidence of abuse potential1,2,5

Abbreviations: AISRS, ADHD Investigator Symptom Rating Scale; CFB, change from baseline; EOS, end of study; LS mean, least squares mean; mITT, modified intent to treat; SE, standard error.

Post Hoc Data

Long-term safety and efficacy trial of Qelbree in adult patients (n=159)2

 

OLE study (P311): Qelbree 200 mg/day to 600 mg/day2

Methodology2

Open-label, long-term, multicenter, flexible dose study of Qelbree in adults with ADHD who completed Study P306. Subjects received Qelbree 200 mg/day during the first 2 weeks of the study. After Visit 2, Qelbree could be titrated up or tapered by 50 mg increments based on response and tolerability (200 mg/day to 600 mg/day). The number of patients at each time point was: (n=159) at the start of OLE, (n=112) at week 12, and (n=51) at week 52. After week 12, subjects were allowed to use certain approved concomitant ADHD medications (n=9).

Primary objective2

Gather long-term safety data on Qelbree

Secondary objective2

Efficacy data during open-label use.

Total daily dose of Qelbree in adults following 52 weeks of treatment in the OLE study2

  • OLE mean dose at week 52 was 427 mg/day (n=39)

Long-term data: AISRS Total Score in the OLE analysis at 12 months2

 

Mean change from baseline in AISRS Total Score2

P311 (OLE): Overall baseline AISRS Total Score was 38.1 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 AISRS Total Score or make any other long-term safety or efficacy conclusions2
  • Enrollment in the OLE safety trial was temporarily closed due to COVID-19 pandemic restrictions; therefore, some subjects did not roll over into the OLE immediately after the DB week 6 (EOS) visit
  • No new safety signals observed for Qelbree 200 mg/day to 600 mg/day (427 mg/day mean dose at week 52) in the OLE (P311)2

Abbreviations: COVID-19, novel coronavirus disease 2019; DB, double blind; OLE, open-label extension.

Post Hoc Data

Post hoc analysis: CFB in AISRS Total Score data based on prior stimulant use in adults with ADHD

Methodology2

This post hoc analysis was conducted using phase III trial data (P306) in adults with ADHD. Participants were stratified based on prior history of reported stimulant use (using medication history at enrollment). The purpose of this analysis was to evaluate the CFB in AISRS Total Score for Qelbree based on prior reported stimulant use

Participants using stimulants at the screening visit underwent a ≥1 week washout period before randomization

 

CFB in AISRS Total Score data based on prior stimulant use at 6 weeks2

  • Participants randomized to Qelbree: AISRS scores at week 6 were not statistically different regardless of prior stimulant use2

This analysis was limited by its post hoc nature, including lack of an a priori power analysis, and the small sample size of the prior stimulant user group. These data are descriptive and conclusions cannot be drawn.2

Efficacy Adults

Healthcare providers are widely prescribing Qelbree2

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Qelbree dosing Efficacy in children 6-11 years 

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. Data on file, Supernus Pharmaceuticals.  3. US Food and Drug Administration. Summary review, NDA approval 21-411. November 26, 2002. Accessed May 11, 2023.  4. Food and Drug Administration. Novel drug approvals for 2021. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021. Accessed May 11, 2023  5. Yaganita T, Wakasa Y, Kiyohara H. Drug dependence potential of viloxazine hydrochloride tested in rhesus monkeys. Pharmacol Biochem Behav. 1979;12(1):155-161.

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.