Long-Term Safety Data for Pediatric ADHD Treatment Option (Ages 6 Years and Older)

DATA UPDATE

Long-term treatment with Qelbree in children and adolescents 6 to 17 years old with ADHD: SAFETY and EFFICACY DATA

Data update including long-term safety and efficacy data for pediatric patients 6 years of age and older.


INDICATION

Qelbree is indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.

Please see full Important Safety Information to the top left.

Qelbree is a first-line, FDA-approved, nonstimulant treatment option for adults and pediatric patients 6 years and older with ADHD.¹

Several clinical studies evaluated the efficacy and safety of Qelbree for ADHD treatment in patients 6 years and older.^1,2

Qelbree phase III pediatric trials designed to assess efficacy and safety of Qelbree in children and adolescents with ADHD^1,2

Methodology¹: Randomized, DB, placebo-controlled, fixed-dose, parallel-group, multicenter studies of children 6 to 11 years of age with ADHD (Study P301 and P303) and teens 12 to 17 years of age (Study P302) with a baseline ADHD-RS-5 Total Score ≥28, CGI-S ≥4. The primary endpoint was CFB in the ADHD-RS-5 Total Score at EOS. Results¹: Total scores at EOS were significantly reduced with Qelbree vs placebo. The CFB in ADHD-RS-5 Total Score at EOS (Week 6) (Study P301) (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. The CFB in ADHD-RS-5 Total Score at EOS (Week 6) (Study P302) (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.
 

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

Please see full Important Safety Information to the top left.

Qelbree phase III pediatric trial results¹:

Qelbree met the primary endpoint (change from baseline in the ADHD-RS-5 Total Score at EOS [Week 6] for Study P301 and P302). P301 study results¹: ADHD-RS-5 Total Score at EOS was significantly reduced with Qelbree vs placebo. The CFB in ADHD-RS-5 Total Score at EOS was -16.6 for Qelbree 100 mg/day, -17.7 for Qelbree 200 mg/day, and -10.9 for placebo. P302 study results¹: ADHD-RS-5 Total Score at EOS was significantly reduced with Qelbree vs placebo. The CFB in ADHD-RS-5 Total Score at EOS was -16.0 for Qelbree 200 mg/day, -16.5 for Qelbree 400 mg/day, and -11.4 for placebo.
 

IMPORTANT SAFETY INFORMATION

• 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.

Please see full Important Safety Information to the top left.

Long-term, open-label treatment with Qelbree in children and adolescents (P310) with ADHD: safety and efficacy²

Patients who completed a previous DB study of Qelbree for the treatment of ADHD were eligible to enroll in an OLE study. Patients 6 to 11 years of age were initially treated with Qelbree 100 mg/day, and the dose could be adjusted by 100 mg/week to a range of 100 mg/day to 400 mg/day, based on clinical response.* Subpopulation analysis²: Patients 12 to 17 years of age were initially treated with Qelbree 200 mg/day, and the dose could be adjusted by 200 mg/week up to 400 mg/day.* All patients underwent up to 3 visits (up to 12 weeks) for dose optimization. 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 patients could continue in the OLE trial until Qelbree was commercially available. The data presented here include patients who completed visits up to 24 months. Primary objective²: Gather long-term safety data on Qelbree monotherapy for ADHD in the pediatric population.

IMPORTANT SAFETY INFORMATION

• 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

Please see full Important Safety Information to the top left.

Qelbree OLE treatment in children and adolescents with ADHD: safety analysis (Figure 5)²

The primary objective of the OLE trial of Qelbree in children and adolescents (6 to 17 years) was safety. The trial found no new safety signals for children and adolescents taking Qelbree long term. The most common AEs were consistent with those seen in the phase III trials. Study discontinuation rate due to AEs was 8.1%.
 

IMPORTANT SAFETY INFORMATION

• 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

Please see full Important Safety Information to the top left.

Please see full Prescribing Information, including Boxed Warning.

Learn more about Qelbree, an extended-release, nonstimulant medication for ADHD: https://www.QelbreeHCP.com/

References: 

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc. 
2. Data on file, Supernus Pharmaceuticals

QBE.2023-0371 V2