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Triple-bead mixed amphetamine salts improves ADHD symptoms in adolescents during 16-hour treatment period, Phase II data indicate

Friday, October 26 2007 | Comments
Evidence Grade 0 What's This?
Once-daily dosing with triple-bead mixed amphetamine salts (triple-bead MAS), an investigational treatment for attention-deficit/hyperactivity disorder, seems to improve ADHD symptoms in adolescents relative to placebo and demonstrates efficacy throughout a 16-hour treatment period, according to Phase II findings.

Researchers evaluated the duration of efficacy and the safety of triple-bead MAS in 84 adolescents with ADHD. Using a double-blind, crossover study design, the researchers randomized the participants to receive a once-daily dose of triple-bead MAS (25 mg or 50 mg), MAS immediate release (MAS IR) 12.5 mg, and placebo, each for 1 week. Among those randomized to receive the 50 mg dose of triple-bead MAS, the drug was initiated at 25 mg/d and titrated to 50 mg/d at day 4.

Efficacy assessments were conducted in a laboratory school setting adapted for a 16-hour observation period. They included the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scale and the clinician-rated ADHD-Rating Scale-IV (ADHD-RS-IV). The SKAMP scale was administered on days 7, 14, and 21 (ie, at the end of each treatment period) 30 minutes before dosing and at 2, 4, 8, 12, 14, and 16 hours postdose. The ADHD-RS-IV was administered at baseline and on days 7, 14, and 21.

On day 7, the least squares mean SKAMP total scores (averaged for the 16-hour observation period) improved significantly with triple-bead MAS relative to placebo (P<.0001) and MAS IR (P=.0025). Differences between triple-bead MAS and placebo were significant at all postdose assessments, whereas differences between triple-bead MAS and MAS IR were significant from 8 hours through 16 hours postdose. In general, findings for the SKAMP attention and deportment subscales were similar to those observed for the SKAMP total scores (triple-bead MAS vs placebo, P<.0001 for both subscales at all postdose assessments).

The least squares mean ADHD-RS-IV total scores (averaged for the 3 postdose assessments) were significantly better with triple-bead MAS as compared with placebo and MAS IR (P<.0001 for all comparisons). The difference in least squares mean ADHD-RS-IV total scores between triple-bead MAS IR and placebo was -14.49; the corresponding difference between triple-bead MAS and MAS IR was -7.31. Findings for the ADHD-RS-IV inattentiveness and hyperactivity/impulsivity subscale scores were similar to those observed for the total scores.

Treatment-emergent adverse events associated with triple-bead MAS were generally mild to moderate in intensity and were consistent with amphetamine treatment, according to the researchers. They added that the incidence of adverse events was higher with the 50 mg dose of triple-bead MAS relative to the 25 mg dose, which may have been due to the rapid 4-day titration period.

Sharon Wigal, lead author of the study and clinical professor of pediatrics at the University of California, Irvine, told VerusMed that the triple-bead formulation of MAS extends the duration of action of MAS to approximately 16 hours relative to the 10- to 12-hour duration currently available with MAS extended release. (Poster B45.)

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

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