New Amphetamine Formulation extends ADHD coverage to 16 Hours
The Journal of Attention Disorders has published two papers about a new formulation of mixed amphetamine salts that uses a triple bead technology (MAS-TB). This technology allows for a delayed release of the medication and enables a duration of effect up to sixteen hours.
This 16-hour effect is significantly higher than existing stimulant medications which on average last for 8-10 hours. This new formulation is based on patient desire to experience beneficial medication effects from morning through evening.
Previously, Spencer et al. (https://www.ncbi.nlm.nih.gov/pubmed/19012813) reported a 7-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group, dose-optimization study of 272 adults with ADHD. They found that MAS-TB significantly reduced ADHD symptoms, behavioral measures of executive dysfunction and increased quality of life ratings. (Other studies have confirmed the benefit of select medications not only for ADHD symptoms, but for executive dysfunctions as well, although no ADHD medications treat executive dysfunction as well as they treat ADHD.)
An assessment of ADHD symptoms 13 to 16 hours post-dose confirmed the duration of action. The first new paper by Frick et al. (https://www.ncbi.nlm.nih.gov/pubmed/28413925) reported a 6 week, randomized controlled study comparing MAS-TB with placebo. As with the prior study, MAS-TB significantly reduced ADHD symptoms. Mean ± SD pulse and systolic blood pressure increases at end of study were 3.5 ± 10.33 bpm and 0.3 ± 10.48 mmHg, which are medically non-consequential.
In the second new study, Adler et al. (https://www.ncbi.nlm.nih.gov/pubmed/28412886) reported a long-term, open-label, safety study of MAS-TB in adults with ADHD. Of 505 enrolled participants, 266 completed the study. Study discontinuation was more likely for patients taking higher (37.5-75 mg) vs. lower doses (12.5 and 25 mg). Blood pressure and pulse increases were observed at end-of-study. ADHD symptoms decreased modestly during the follow-up period.
The most frequently reported treatment emergent adverse events in both studies were insomnia, decreased appetite, and dry mouth. These observed side effects are similar to those seen for other stimulant medications, and are typically well managed by physicians when they occur by adjusting the dose or changing medications.
