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Proven efficacy

Significant reduction in AISRS total score from CFB to EOS1

Adults 18 years and older

Inattention and hyperactivity/impulsivity symptom score reductions observed as early as week 2.1

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 2.1,2

 

Qelbree is the first nonstimulant approved for adult ADHD in over 20 years1,3

Efficacy_Adults_Small

Phase III trials 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.

Inclusion criteria to include: males or females ages 18 to ≤65 years; ADHD diagnosis (DSM-5) ≥6 months before screening, confirmed with SCID-5-CT; AISRS total score ≥26 at the screening baseline visits; BMI=18.0 to 35 kg/m2; CGI-S score of >4 at the screening baseline visits; FOCP: sexually inactive/using birth control from 30 days before the first dose through completion.

Exclusion criteria to include: previously enrolled in a Qelbree/SPN-812 study; HAM-A score of >21 at screening; SDQ mean score >3.5 at screening (before March 2020), >3.0 at screening (after March 2020); suicidality within 6 months; major psychiatric disorder; major neurological disorder; history of seizures; significant systemic disease; positive drug screen; FOCP: pregnancy, breastfeeding, refusal of abstinence/birth control.

Abbreviations: AISRS, ADHD Investigator Symptom Rating Scale; BMI=body mass index; CGI-S, Clinical Global Impression–Severity of Illness; FOCP, female of childbearing potential; HAM-A, Hamilton Anxiety Rating Scale; SCID-5-CT, Structured Clinical Interview for DSM-5, Clinical Trials Version; SDQ, Symptoms of Depression Questionnaire.

Simple to start

 

Study P3061

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

No study visit was scheduled/performed at week 5

Proven efficacy in a robust clinical trial1

 

Primary efficacy measure: CFB to EOS in AISRS total score vs placebo1 (N=354)

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. Percentage of patients treated by dose at EOS (n=189):
200 mg/day: 8%
400 mg/day: 32%
600 mg/day: 60%

Study P306 results:

Total AISRS 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 adults1
  • Once-daily Qelbree demonstrates proven safety and tolerability with no evidence of abuse potential observed in clinical studies1,4

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

Efficacy_Adults_Interior_Small

Efficacy established in adults (18 to 60 years) in 1 randomized, placebo-controlled trial1

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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. Data on file, Supernus Pharmaceuticals.
2. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.
3. US Food and Drug Administration. Summary review, NDA approval 21-411. November 26, 2002. Accessed February 23, 2022.
4. 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.