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Qelbree offers proven efficacy for adults with ADHD1

Statistically significant reduction in ADHD symptom scores for adults 18 to 65 years of age at EOS (6 weeks).1

Qelbree dosing: Straightforward titration in adult (ages 18-65 years) patients with ADHD1

Study P306: Titration through Week 21,2

 


Inclusion and study design1,3

Study: P306
Age group: 18 to 65 years of age
mITT population: 354
Study medication: Flexible dosing (200 mg/day to 600 mg/day) or matching placebo. No study visit was scheduled/performed at Week 5.

Phase III trial methodology: Randomized, DB, placebo-controlled, multicenter, parallel-group, flexible-dose study of adults 18 to 65 years of age with ADHD (Study P306).2,3

Primary endpoint: CFB in AISRS Total Score at EOS (6 weeks).3

Proven efficacy in treating ADHD at EOS (n=354)1

Primary endpoint met: Significant improvement from baseline of the AISRS Total Score to EOS2

 

Study P306

Study P306 results:

At baseline, the AISRS Total Score was comparable between groups: 38.5 for Qelbree and 37.6 for placebo. AISRS Total Score at EOS was significantly reduced with Qelbree vs placebo. The CFB in AISRS Total Score at EOS was -15.5 for Qelbree and -11.7 for placebo.1

Symptom score reductions observed as early as Week 2
 

Secondary endpoint: Symptom score breakout for inattention and hyperactivity/impulsivity subscales at EOS (6 weeks)2

 

 

60% of adults titrated to the maximum dose at EOS3

Study P306 allowed for proactive titration to ensure each patient reached their ideal dose for symptom control.

504 mg/day was the mean dose at EOS (6 weeks)1

Qelbree OLE trial: Long‑term safety and efficacy data in adult population

 

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

Methodology: 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).2

Primary objective: Long-term safety data2

Secondary objective: Efficacy data during open-label use2

 

OLE Study P311: Mean change from baseline in AISRS Total Score (overall mean baseline was 38.1) n=1592

 

  • 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) visit2

Abbreviations: ADHD, attention-deficit/hyperactivity disorder; AE, adverse event; AISRS, ADHD Investigator Symptom Rating Scale; CFB, change from baseline; DB, double blind; EOS, end of study; LS mean, least-squares mean; mITT, modified intent to treat; OLE, open-label extension; SE, standard error.

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IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree (viloxazine extended-release capsules) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults 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 [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.  2. Data on file, Supernus Pharmaceuticals, Inc.  3. Nasser A, Hull JT, Chaturvedi SA, et al. A phase III, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of viloxazine extended-release capsules in adults with attention-deficit/hyperactivity disorder. CNS Drugs. 2022;36(8):897-915. doi:10.1007/s40263-022-00938-w

IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree (viloxazine extended-release capsules) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults 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.