ed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) in the adjunctive trial with INTUNIV were: somnolence, fatigue, insomnia, dizziness, and abdominal pain. Most Common Adverse Reactions -®
In the adjunctive clinical study, 3% of patients receiving INTUNIV discontinued due to adverse reactions, compared to 1% in the placebo group. Each adverse reaction leading to discontinuation occurred in less than 1% of INTUNIV -treated patients. Adverse Reactions Leading to Discontinuation –®®
Short Term Monotherapy Clinical Studies
- Two short-term, placebo-controlled, double-blind pivotal studies (Studies 1 and 2) were conducted in children and adolescents with ADHD, using fixed doses of INTUNIV (1 mg, 2 mg, 3 mg, and 4 mg/day). The most commonly reported adverse reactions (occurring in ≥ 2% of patients) that were considered drug-related and reported in a greater percentage of patients taking INTUNIV compared to patients taking placebo are shown in Table 2. Adverse reactions that were dose-related include: somnolence/sedation, abdominal pain, dizziness, hypotension, dry mouth and constipation. Common Adverse Reactions®®
Table 2: Percentage of Patients Experiencing Common (≥ 2%) Adverse Reactions in Short-Term
Monotherapy Studies 1 and 2
Adverse Reaction Term All Doses of INTUNIV (N=513)
®
Placebo
(N=149)
Somnolence a 38% 12%
Headache 24% 19%
Fatigue 14% 3%
Abdominal pain b 11% 9%
Hypotension c 7% 3%
Nausea 6% 2%
Lethargy 6% 3%
Dizziness 6% 4%
Irritability 6% 4%
Decreased appetite 5% 3%
Dry mouth 4% 1%
Constipation 3% 1%
a: The somnolence term includes somnolence, sedation, and hypersomnia. b: The abdominal pain term includes abdominal pain, abdominal pain upper, and abdominal pain lower. c: The hypotension term includes hypotension, orthostatic hypotension, and decreased blood pressure.
In an 8-week, placebo-controlled study in children 6-12 years of age with ADHD in which INTUNIV was dosed once (1-4 mg/day) in the morning or evening (Study 4), the safety profile was consistent with the once daily morning dosing of INTUNIV . ®®
Short Term Adjunctive Clinical Study
- A 8-week, placebo-controlled, double-blind, dose-optimized pivotal study (Study 3) was conducted in children and adolescents aged 6-17 years with a diagnosis of ADHD who were identified as having a sub-optimal response to psychostimulants. Patients received INTUNIV (1 mg, 2 mg, 3 mg, and 4 mg/day) or placebo, dosed in the morning or in the evening, in combination with their morning dose of psychostimulant. The most commonly reported adverse reactions (occurring in ≥ 2% of patients in the overall INTUNIV group) that were reported in a greater percentage of patients taking INTUNIV compared to patients taking placebo are shown in Table 3. Common Adverse Reactions®& |
