« Back

Triple-bead MAS improves ADHD symptoms in adults, data indicate

Tuesday, October 30 2007 | Comments

---

What's This? Triple-bead mixed amphetamine salts (MAS), an investigational formulation of MAS designed for once-daily dosing, significantly improves symptoms of attention-deficit/hyperactivity disorder in adults, according to findings from 2 Phase III trials.

The double-blind trials enrolled adults aged 18 to 55 years with ADHD. In the first, a dose-optimization study, 274 subjects were randomized to receive triple-bead MAS (12.5 mg to 75 mg) or placebo for 7 weeks. In the second, a forced-titration study, 411 participants were randomized to receive placebo or MAS 25 mg/day, 50 mg/d, or 75 mg/d for 6 weeks.

The primary efficacy measure in both trials was the change from baseline to endpoint in the clinician-rated ADHD Rating Scale-IV (ADHD-RS-IV) total score, with endpoint defined as the average of the values collected at weekly visits during the last 3 weeks of each study (or the last postrandomization treatment assessment with a valid score).

Data from both studies showed that triple-bead MAS was associated with significantly greater improvements in mean ADHD-RS-IV total score relative to placebo. Specifically, the least squares mean change from baseline to endpoint with triple-bead MAS was -14.4 in the dose-optimization study (vs -6.3 with placebo; P<.0001) and -19.6 in the forced-titration study (vs -9.1 with placebo; P<.0001). Results were similar when the individual doses in the forced-titration study were each compared with placebo (P<.0001 for all 3 comparisons).

The frequency of treatment-emergent adverse events declined with time, the authors noted. They added that most of these events were mild to moderate in severity and were consistent with those typically associated with amphetamine treatment. Overall, treatment-emergent adverse events were more frequently reported with triple-bead MAS (dose-optimization study, 89.1%; forced-titration study, 81.8%) than with placebo (63.7% and 61.5%, respectively); the most common were insomnia, dry mouth, decreased appetite, headache, and decreased weight.

In the dose-optimization study, insomnia was reported by 29.2% of triple-bead MAS-treated patients compared with 8.9% of placebo-treated patients; the corresponding numbers in the forced-titration study were 41.7% and 12.5%. However, Pittsburgh Sleep Quality Index (PSQI) scores suggested no impairment of sleep quality with triple-bead MAS. Specifically, the mean PSQI score improved by 1.9 points among patients treated with MAS and by 1.7 points among placebo-treated patients in the dose-optimization study. Similarly, in the forced-titration study, the mean PSQI score improved by 1.7 points with triple-bead MAS and by 1.5 points with placebo. (Goodman DW, et al. Poster D21.)

This information concerns a use that has not been approved by the Food and Drug Administration.

Print  |  E-mail