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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.

What are the benefits of this drug?

Table 1 summarizes efficacy results for the evaluated patients in the three clinical trials. The primary endpoint was the change from baseline (reduction) in ADHD Rating Scale-5 (ADHD-RS-5) total score at Week 6. The number of patients representing efficacy findings may differ from the number of patients representing safety findings due to different pools of study participants analyzed for efficacy and safety.

Table 1: Primary Efficacy Results for Change from Baseline in ADHD-RS-5 Total Score in Pediatric Patients (6 to 17 years) with ADHD (Studies 1, 2, 3)

Table 1 summarizes the efficacy results from the Study 1, 2, and 3 clinical trials based on the change from baseline in the Attention Deficit Hyperactivity Disorder (ADHD Rating Scale-5 total score in pediatric ADHD participants receiving QELBREE or placebo.

Source: QELBREE Prescribing Information

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.

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

Tables 2, 3, and 4 below summarize the efficacy results by sex, race, and age, respectively, for Study 1. Tables 5, 6, and 7 below summarize the efficacy results by sex, race, and age, respectively, for Study 2. Tables 8, 9, and 10 below summarize the efficacy results by sex, race, and age, respectively, for Study 3. In all subgroup analyses, the primary endpoint was the change from baseline in ADHD-RS-5 total score at Week 6; the analysis population was the intent-to-treat (ITT) population, defined as all randomized subjects who took at least one dose of study medication and had a baseline and at least one post-baseline ADHD-RS-5 assessment.

Table 2. Study 1 – Subgroup Analysis by Sex: ADHD-RS-5 Total Score (ITT)

Treatment Group Baseline LS Mean Change from Baseline LS Mean Difference from Placebo
N Mean
(SD*)
N Mean SE# Mean SE#
Male
Placebo 97 43.4
(7.19)
87 -10.6 1.48 -- --
QELBREE
100 mg/day
94 45.2
(6.77)
87 -15.2 1.49 -4.6 2.09
QELBREE
200 mg/day
99 44.4
(6.90)
95 -18.0 1.44 -7.3 2.05
Female
Placebo 58 43.8
(6.85)
54 -11.0 1.78 -- --
QELBREE
100 mg/day
53 44.8
(6.13)
52 -18.7 1.84 -7.6 2.51
QELBREE
200 mg/day
59 43.4
(6.65)
51 -17.4 1.77 -6.4 2.48

Source: FDA Review

* Standard deviation, # standard error, ◊ least squares

Table 3. Study 1 – Subgroup Analysis by Race: ADHD-RS-5 Total Score (ITT)

Treatment Group Baseline LS Mean Change from Baseline LS Mean Difference from Placebo
N Mean
(SD*)
N Mean SE# Mean SE#
White
Placebo 77 43.0
(7.62)
73 -10.6 1.64 -- --
QELBREE
100 mg/day
76 45.1
(6.46)
73 -17.9 1.66 -7.2 2.33
QELBREE
200 mg/day
83 44.0
(7.09)
80 -18.4 1.58 -7.8 2.27
Other races
Placebo 78 44.1
(6.44)
68 -11.5 1.59 -- --
QELBREE
100 mg/day
71 44.9
(6.64)
66 -15.2 1.62 -3.7 2.24
QELBREE
200 mg/day
75 44.0
(6.52)
66 -17.0 1.58 -5.5 2.21

Source: FDA Review

* Standard deviation, # standard error, ◊ least squares

Table 4. Study 1 – Subgroup Analysis by Age: ADHD-RS-5 Total Score (ITT)

Treatment Group Baseline LS Mean Change from Baseline LS Mean Difference from Placebo
N Mean
(SD*)
N Mean SE# Mean SE#
Age 6-9
Placebo 103 44.6 (6.22) 92 -9.8 1.44 -- --
QELBREE
100 mg/day
103 45.9 (6.02) 97 -16.5 1.42 -6.7 2.03
QELBREE
200 mg/day
107 44.3 (6.58) 96 -17.5 1.38 -7.7 2.01
Age 10-11
Placebo 52 41.4 (8.11) 49 -12.4 1.80 -- --
QELBREE
100 mg/day
44 43.0 (7.24) 42 -16.0 1.96 -3.6 2.67
QELBREE
200 mg/day
51 43.3 (7.27) 50 -17.5 1.81 -5.1 2.56

Source: FDA Review

* Standard deviation, # standard error, ◊ least squares

Table 5. Study 2 - Subgroup Analysis by Sex: ADHD-RS-5 Total Score (ITT)

Treatment Group Baseline LS Mean Change from Baseline LS Mean Difference from Placebo
N Mean
(SD*)
N Mean SE# Mean SE#
Female
Placebo 36 44.4
(6.95)
35 -13.7 2.52 -- --
QELBREE
200 mg/day
33 44.8
(6.78)
31 -20.3 2.67 -6.6 3.63
QELBREE
400 mg/day
38 43.5
(6.45)
32 -18.3 2.54 -4.6 3.55
Male
Placebo 61 43.0
(6.71)
57 -10.8 1.85 -- --
QELBREE
200 mg/day
74 43.4
(6.42)
68 -16.6 1.71 -5.7 2.50
QELBREE
400 mg/day
59 46.0
(6.46)
53 -16.9 1.93 -6.0 2.66

Source: FDA Review

* Standard deviation, # standard error, ◊ least squares

Table 6. Study 2 – Subgroup Analysis by Race: ADHD-RS-5 Total Score (ITT)

Treatment Group Baseline LS Mean Change from Baseline LS Mean Difference from Placebo
N Mean
(SD*)
N Mean SE# Mean SE#
White
Placebo 53 43.8
(6.79)
52 -13.7 2.05 -- --
QELBREE
200 mg/day
54 43.9
(6.27)
51 -20.1 2.07 -6.4 2.90
QELBREE
400 mg/day
52 45.0
(6.65)
49 -20.4 2.12 -6.7 2.92
Other races
Placebo 44 43.2
(6.86)
40 -9.2 2.08 -- --
QELBREE
200 mg/day
53 43.7
(6.85)
48 -15.0 1.92 -5.8 2.80
QELBREE
400 mg/day
45 45.0
(6.49)
36 -13.9 2.12 -4.7 2.95

Source: FDA Review

* Standard deviation, # standard error, ◊ least squares

Table 7: Study 2 – Subgroup Analysis by Age: ADHD-RS-5 Total Score (ITT)

Treatment Group Baseline LS Mean Change from Baseline LS Mean Difference from Placebo
N Mean (SD*) N Mean SE# Mean SE#
Age 6-9
Placebo 64 44.0 (6.76) 61 -11.2 1.84 -- --
QELBREE
200 mg/day
71 44.3 (6.40) 64 -17.4 1.79 -6.2 2.56
QELBREE
400 mg/day
68 45.6 (6.29) 59 -18.5 1.83 -7.3 2.60
Age 10-11
Placebo 33 42.7 (6.88) 31 -11.6 2.43 -- --
QELBREE
200 mg/day
36 42.8 (6.78) 35 -17.5 2.32 -5.9 3.36
QELBREE
400 mg/day
29 43.7 (7.04) 26 -14.3 2.63 -2.7 3.58

Source: FDA Review

* Standard deviation, # standard error, ◊ least squares

Table 8. Study 3 – Subgroup Analysis by Sex: ADHD-RS-5 Total Score (ITT)

Treatment Group Baseline LS Mean Change from Baseline LS Mean Difference from Placebo
N Mean (SD*) N Mean SE# Mean SE#
Male
Placebo 58 40.7 (6.48) 57 -8.70 1.77 -- --
QELBREE
200 mg/day
66 40.2 (7.14) 60 -15.8 1.66 -7.0 2.39
QELBREE
400 mg/day
67 39.3 (7.77) 62 -18.0 1.64 -9.3 2.38
Female
Placebo 46 40.3 (7.23) 45 -14.7 2.15 -- --
QELBREE
200 mg/day
28 39.3 (7.52) 28 -16.5 2.77 -1.9 3.50
QELBREE
400 mg/day
36 39.4 (7.35) 36 -13.9 2.43 0.8 3.25

Source: FDA Review

* Standard deviation, # standard error, ◊ least squares

Table 9. Study 3 – Subgroup Analysis by Race: ADHD-RS-5 Total Score (ITT)

Treatment Group Baseline LS Mean Change from Baseline LS Mean Difference from Placebo
N Mean
(SD*)
N Mean SE# Mean SE#
White
Placebo 63 40.5
(6.64)
62 -12.3 1.73 -- --
QELBREE
200 mg/day
53 40.3
(7.04)
53 -19.7 1.87 -7.3 2.54
QELBREE
400 mg/day
55 38.8
(7.41)
54 -16.5 1.85 -4.1 2.52
Other races
Placebo 41 40.5
(7.11)
40 -9.9 2.19 -- --
QELBREE
200 mg/day
41 39.4
(7.51)
35 -10.3 2.28 -0.4 3.10
QELBREE
400 mg/day
48 40.0
(7.82)
44 -16.3 2.05 -6.4 2.96

Source: FDA Review

* Standard deviation, # standard error, ◊ least squares

Table 10. Study 3 – Subgroup Analysis by Age: ADHD-RS-5 Total Score (ITT)

Treatment Group Baseline LS Mean Change from Baseline LS Mean Difference from Placebo
N Mean (SD*) N Mean SE# Mean SE#
Age 12-14
Placebo 70 41.6 (6.36) 68 -9.7 1.62 -- --
QELBREE
200 mg/day
63 41.0 (6.80) 58 -16.9 1.73 -7.1 2.37
QELBREE
400 mg/day
64 40.3 (7.37) 60 -16.4 1.71 -6.7 2.36
Age 15-17
Placebo 34 38.3 (7.21) 34 -15.1 2.44 -- --
QELBREE
200 mg/day
31 37.8 (7.70) 30 -14.4 2.57 0.7 3.55
QELBREE
400 mg/day
39 37.8 (7.77) 38 -16.7 2.30 -1.7 3.35

Source: FDA Review

* Standard deviation, # standard error, ◊ least squares

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.

What are the possible side effects (results of trials used to assess safety)?

Table 11: Adverse Reactions Reported in ≥2% of Pediatric Patients (6 to 17 Years of Age) Treated with QELBREE and at a Rate Greater than Placebo-Treated Patients in Placebo-Controlled ADHD Studies

Body System Adverse Reaction Placebo
N=463 (%)

QELBREE

100mg
N=154 (%)
200mg
N=367 (%)
400mg
N=305 (%)
All QELBREE
N=826 (%)
Nervous system disorders
Somnolence* 4 12 16 19 16
Headache* 7 10 11 11 11
Metabolic and nutritional disorders
Decreased appetite 0.4 5 8 8 7
Infections and infestations
Upper respiratory tract infection* 6 5 7 8 7
Body as a Whole – General disorders
Fatigue 2 4 5 9 6
Pyrexia 0.2 3 2 1 2
Gastrointestinal system disorders
Abdominal Pain* 4 3 6 7 5
Nausea 3 1 4 7 5
Vomiting 2 5 3 6 4
Psychiatric disorders
Insomnia* 1 2 5 5 4
Irritability 1 3 2 5 3

Source: QELBREE Prescribing Information

*The following terms were combined:
Somnolence: somnolence, lethargy, sedation
Headache: headache, migraine, migraine with aura, tension headache
Upper respiratory tract infection: nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, viral sinusitis, viral upper respiratory tract infection
Abdominal pain: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper
Insomnia: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia

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.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

Table 12: Adverse Events by Demographic Subgroup, Safety Population

Characteristic Treatment
N=826
[n/Ns (%)]
Placebo
N=463
[n/Ns (%)]
Sex, n (%)
Male 282/539 (52.3) 93/285 (32.6)
Female 140/287 (48.7) 78/178 (43.8)
Age group, years, n (%)
6-9 187/356 (52.5) 59/175 (33.7)
10-11 78/166 (47) 35/87 (40.2)
12-14 99/193 (51.2) 49/134 (36.6)
15-17 58/111 (52.2) 28/67 (41.8)
Race, n (%)
American Indian or Alaska Native 5/5 (100) 4/4 (100)
Black or African American 165/340 (48.5) 51/175 (29.1)
Multiple 19/31 (61.2) 9/19 (47.4)
White 231/448 (51.6) 105/263 (39.9)
Asian 2/2 (100) 2/2 (100)

Source: FDA Review

Abbreviations: N, number of subjects in treatment group; n, number of subjects with given characteristic; Ns, number of subjects in subgroup

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

Who participated in the trials?

Table 13: Baseline Demographic Characteristics, Safety Population

  Ages 6 to 11 Years Ages 12 to 17 Years Total
Characteristic Treatment
N=522
Placebo
N=262
Treatment
N=304
Placebo
N=201
Treatment
N=826
Placebo
N=463
Sex, n (%)
Male 335 (64) 166 (63) 204 (67) 119 (59) 611 (66) 285 (62)
Female 187 (36) 96 (37) 100 (33) 82 (41) 314 (34) 178 (38)
Age group, years, n (%)
6–9 356 (68) 175 (67) 0 0 356 (39) 175 (38)
10–11 166 (32) 87 (33) 0 0 166 (18) 87 (19)
12–14 0 0 193 (63) 134 (67) 267 (29) 134 (29)
15–17 0 0 111 (37) 67 (33) 136 (15) 67 (15)
Race, n (%)
American Indian or Alaska Native 2 (0.4) 3 (1) 3 (1) 1 (1) 6 (1) 4 (1)
Black or African American 226 (43) 111 (42) 114 (38) 64 (32) 368 (40) 175 (38)
Multiple 22 (4) 11 (4) 9 (3) 8 (4) 33 (4) 19 (4)
White 272 (52) 135 (52) 176 (58) 128 (64) 515 (56) 263 (57)
Asian 0 2 (1) 2 (<1) 0 2 (0.2) 2 (0.4)

Source: FDA Review

Includes participants enrolled in the Study 1, 2, and 3 clinical trials and a 4th pharmacokinetic (PK) trial in healthy volunteers treated with approved doses of QELBREE

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.

How were the trials designed?

In Study 1, the benefit of QELBREE was evaluated in children 6 to 11 years of age with ADHD. A total of 477 pediatric patients were randomly assigned to receive one of three treatments (100 mg QELBREE, 200 mg QELBREE, or placebo) once a day for 6 weeks. The overall improvement of ADHD symptoms observed at Week 6 of treatment was significantly greater in children who received either 100 mg or 200 mg QELBREE compared with children who received placebo.

In Study 2, the benefit of QELBREE was evaluated in children 6 to 11 years of age with ADHD. A total of 313 children were randomly assigned to receive one of three treatments (200 mg QELBREE, 400 mg QELBREE, or placebo) once a day for 8 weeks. The overall improvement of ADHD symptoms observed at Week 8 of treatment was significantly greater in children who received either 200 mg or 400 mg QELBREE compared with children who received placebo.

In Study 3, the benefit of QELBREE was evaluated in adolescents 12 to 17 years of age with ADHD. A total of 310 adolescent patients were randomly assigned to receive one of three treatments (200 mg QELBREE, 400 mg QELBREE, or placebo) once a day for 6 weeks. The overall improvements of ADHD symptoms observed at Week 6 of treatment was significantly greater in adolescents who received either 200 mg or 400 mg QELBREE compared with adolescents who received placebo.

In addition to Studies 1, 2, and 3, a fourth study provided information about the safety of QELBREE in adolescents 12 to 17 years of age with ADHD. In these four studies, a total of 826 patients 6 to 17 years of age received treatment with QELBREE and 463 patients received placebo. The most common side effects were sleepiness, decreased appetite, tiredness, nausea, vomiting, trouble sleeping, and irritability. Other important side effects included an increased risk of suicidal ideation and behavior, increases in blood pressure and heart rate, and effects on weight.

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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