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Drug Trials Snapshots: QELBREE

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the QELBREE Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

QELBREEE (viloxazine)
Kel’ bree
Supernus Pharmaceuticals, Inc.
Approval date: April 2, 2021


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

QELBREE is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in children 6 to 17 years of age.

How is this drug used?

QELBREE extended-release capsules are taken orally one time each day. The healthcare provider will determine the dose of QELBREE.

What are the benefits of this drug?

The benefit of QELBREE (100, 200, and 400 mg) was evaluated in three clinical studies, including two in children (ages 6 to 11 years) and one in adolescents (ages 12 to 17 years) with ADHD. In each study, pediatric patients were randomly assigned to receive one of two doses of QELBREE or placebo once daily for 6 to 8 weeks. None of the patients, their parent(s)/caregiver(s), the study sponsor, or the study doctors knew which treatment the patient received during the study. The severity of ADHD symptoms observed at the last week of treatment was significantly greater in patients who received placebo compared with patients who received QELBREE 100 mg, 200 mg, and 400mg.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: QELBREE worked similarly in male and female patients.
  • Race: QELBREE worked similarly in different racial groups.
  • Age: QELBREE worked similarly in the age groups studied.

What are the possible side effects?

The most common side effects of QELBREE are sleepiness, decreased appetite, tiredness, nausea, vomiting, trouble sleeping, and irritability. QELBREE can increase the risk of suicidal thoughts or actions. Other possible side effects of QELBREE include increased blood pressure and heart rate, manic episodes, and effects on weight.

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in male and female patients.
  • Race: The occurrence of side effects was similar in different racial groups.
  • Age: The occurrence of side effects was similar in patients ages 6 to 11 years and patients ages 12 to 17 years.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the trials?

The FDA approved QELBREE based on evidence from several clinical trial(s) of 1289 patients with attention deficit hyperactivity disorder (ADHD). The trials were conducted at 59 of sites in the United States.

Figure 1 summarizes how many males and females were enrolled in the three combined clinical trials used to evaluate the efficacy of QELBREE.

Figure 1: Baseline Demographics by Sex – Efficacy Population

Figure 1 is a pie chart summarizing how many pediatric participants by sex were evaluated efficacy in the Study 1, 2, and 3 clinical trials.  Of the 1062 participants, 675 (64%) were male and 387 (36%) were female.

Source: FDA Review

Figure 2 below summarizes how many patients by sex were in the combined trials (Studies 1, 2, and 3, and a PK study) used to evaluate the side effects of QELBREE.

Figure 2: Baseline Demographics by Sex – Safety Population

Figure 2 below summarizes how many patients by sex were in the combined trials (Studies 1, 2, and 3, and a PK study) used to evaluate the side effects of QELBREE.

Source: FDA Review

Figure 3 summarizes the percentage of patients by race enrolled in the three combined clinical trials used to evaluate the efficacy of QELBREE.

Figure 3: Baseline Demographics by Race – Efficacy Population

Figure 3 summarizes the percentage of patients by race enrolled in the three combined clinical trials used to evaluate the efficacy of QELBREE.

Source: FDA Review

Figure 4 summarizes how many patients by race were in the combined trials (Studies 1, 2, and 3, and a PK study) used to evaluate the side effects of QELBREE.

Figure 4: Demographics of Safety Trials by Race

Figure 4 summarizes how many patients by race were in the combined trials (Studies 1, 2, and 3, and a PK study) used to evaluate the side effects of QELBREE.

Source: FDA Review

Figure 5 summarizes the percentage of patients by age enrolled in the three combined clinical trials used to evaluate the efficacy of QELBREE.

Figure 5: Baseline Demographics by Age (in Years) – Efficacy Population

Figure 5 summarizes the percentage of patients by age enrolled in the three combined clinical trials used to evaluate the efficacy of QELBREE.

Source: FDA Review

Figure 6 summarizes how many patients by age were in the combined trials (Studies 1, 2, and 3, and a PK study) used to evaluate the side effects of QELBREE.

Figure 6: Baseline Demographics by Age (in Years) – Safety Population

Figure 6 is a pie chart summarizes how many patients by age were in the combined trials (Studies 1, 2, and 3, and a PK study) used to evaluate the side effects of QELBREE.

Source: FDA Review

How were the trials designed?

QELBREE was evaluated in four clinical trials of patients with attention deficit hyperactivity disorder (ADHD).

Three studies were conducted to assess the benefit and safety of QELBREE in children and adolescents (6 to 17 years of age) with attention deficit hyperactivity disorder (ADHD). The severity of ADHD symptoms was assessed using the Attention-Deficit Hyperactivity Disorder Rating Scale 5th Edition (ADHD-RS-5) before treatment (baseline) and every week during treatment, including the final week (endpoint). A fourth study provided information about the safety of QELBREE in adolescents 12 to 17 years of age with ADHD.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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