Having already received approval for its new attention deficit hyperactivity disorder treatment Vyvanse for children, Shire is now asking US regulators to back the drug for use in adults.
The UK drugmaker has submitted a supplemental New Drug Application to the US Food and Drug Administration for Vyvanse (lisdexamfetamine dimesylate) for ADHD in adults and Shire expects the agency’s review to take around 10 months. Shire chief executive Matthew Emmens said it was important to remember that ADHD is “a treatable disorder that affects adults as well as children,” and claimed that the firm was pleased with the results of Vyvanse Phase III studies conducted in adults, the data from which will be presented at a major scientific conference in the fourth quarter of this year.
The announcement came as Shire began marketing Vyvanse for children aged 6 to 12 in the USA. A company spokeswoman told PharmaTimes World News that a field force of around 500 started hitting the streets yesterday to promote the treatment which was approved by the FDA in February and it is Shire’s aim to switch patients to Vyvanse from its current top-selling blockbuster Adderall XR (mixed amphetamine salts), which becomes genericised in 2009, as well as take market share from competitors in ADHD, such as GlaxoSmithKline’s Dexedrine (dextroamphetamine), Johnson & Johnson’s Concerta and Novartis’ Ritalin (both methylphenidate).
The spokeswoman said that Shire is selling Vyvanse at the same price as Adderall XR – $3.40 a day – but declined to give any timelines regarding the switch from the older product. The company is confident that it can differentiate the compound from other ADHD products, given Vyvanse’s extended duration of effect and the claim that it is less open to abuse than existing treatments. By Kevin Grogan
