After submitting a New Drug Application to the FDA in July, Shire Pharmaceuticals has recently announced the results of Phase II trials of the investigational medication-an amphetamine compound that could require only a once daily dose to control symptoms for up to 16 hours.
In two separate trials, participants taking the medication had significantly higher scores on tests of attention and ability to stay on tasks than did those taking a placebo. These results remained significant even at 16 hours after drug administration.
While the investigational drug did have some side effects, such as insomnia, decreased appetite, and headaches, these were not different from the side effects of other ADHD medications currently available.
The FDA is currently reviewing the New Drug Application for this medication.