Shire claims that unlike some other ADHD treatments, Intuniv is not a controlled substance and does not have a known mechanism for potential abuse or dependence.
“The information requested by the FDA was not unexpected, and Shire is working with the FDA to provide a full and timely response to the agency’s request,” the company said in a statement.
When approved, Intuniv will be the first medication indicated to treat ADHD symptoms by selectively targeting alpha-2A-receptors in the prefrontal cortex, an area of the brain that is thought to manage executive functioning tasks, according to Shire’s CEO, Matthew Emmens.