: standard deviation; SE: standard error; 95% CI (unadjusted) Doses were shown to be statistically significantly superior to placebo.
a
Study 3: Flexible-dose INTUNIV as Adjunctive Therapy to Psychostimulants ®
Study 3 was a double-blind, randomized, placebo-controlled, dose-optimization study, in which efficacy of once daily optimized dosing (morning or evening) with INTUNIV (1mg, 2mg, 3mg and 4mg), when co-administered with psychostimulants, was eva luated for 8 weeks, in children and adolescents aged 6-17 years with a diagnosis of ADHD, with a sub-optimal response to stimulants (n=455). Subjects were started at the 1 mg INTUNIV dose level and were titrated weekly over a 5-week dose-optimization period to an optimal INTUNIV dose not to exceed 4 mg/day based on tolerability and clinical response. The dose was then maintained for a 3-week dose maintenance period before entry to 1 week of dose tapering. Subjects took INTUNIV either in the morning or the evening while maintaining their current dose of psychostimulant treatment given each morning. Allowable psychostimulants in the study were ADDERALL XR , VYVANSE , CONCERTA , FOCALIN XR , RITALIN LA , METADATE CD or FDA-approved generic equivalents. ®®®®®®®®®®
Symptoms of ADHD were eva luated on a weekly basis by clinicians using the ADHD Rating Scale (ADHD-RS-IV), which includes both hyperactive/impulsive and inattentive subscales. The primary efficacy outcome was the change from baseline to endpoint in ADHD-RS-IV total scores. Endpoint was defined as the last post-randomization treatment week prior to dose tapering for which a valid score was obtained (up to Week 8).
Mean reductions in ADHD-RS-IV total scores at endpoint were statistically significantly greater for INTUNIV given in combination with a psychostimulant compared to placebo given with a psychostimulant for Study 3, for both morning and evening INTUNIV dosing (see Table 7). Nearly two-thirds (64.2%) of subjects reached optimal doses in the 0.05-0.12 mg/kg/day range. ®®
Study 4: Flexible-dose INTUNIV Monotherapy ®
Study 4 was a double-blind, randomized, placebo-controlled, dose-optimization study, in which efficacy of once daily dosing (morning or evening) with INTUNIV (1mg, 2mg, 3mg, and 4mg) was eva luated for 8 weeks in children aged 6-12 years (n=340). ®
Signs and symptoms of ADHD were eva luated on a once weekly basis using the clinician administered and scored ADHD Rating Scale (ADHD-RS-IV), which includes both hyperactive/impulsive and inattentive subscales. The primary efficacy outcome was the change from baseline score at endpoint on the ADHD-RS-IV total scores. Endpoint was defined as the last post-randomization treatment week for which a valid score was obtained prior to dose tapering (up to Week 8).
Mean reductions in ADHD-RS-IV total scores at endpoint were statistically significantly greater for INTUNIV compared to placebo in both AM and PM dosing groups of INTUNIV (see Table 7). ®®
Table 7: Flexible-Dose studies
Study (Age Range)
Treatm |
