The schedule II designator is applied to drugs considered to have a high likelihood of being abused and additional prescribing safeguards are put in place. Shire said that it anticipated the decision, as all ADHD stimulant medications have historically been classified as Schedule II controlled substances.
Shire also said that clinical studies suggest that Vyvanse has a lower abuse potential profile than other ADHD drugs, and could use this as a point of differentiation.
Matthew Emmens, Shire CEO, said: “Vyvanse is the first ADHD stimulant to have the results of abuse liability studies reflected in its product label. Shire plans to continue to build the body of evidence in support of a lower abuse potential profile.”
Shire acquired Vyvanse as part of its merger with New River, the company that had collaborated with Shire on the development of the ADHD treatment. Vyvanse is a potential successor to Adderall, which makes up more than half of Shire’s sales and lose patent protection in 2009. Shire said that the product launch of Vyvanse remains on track for Q2 2007.