Shire's ADHD remedy Vyvanse didn't exactly ace its Phase II testing as a depression treatment. But the British drugmaker aims to develop the product as an add-on for major depression anyway. The company says that it intends to talk to regulators about how to structure a Phase III program.
In a 14-week double-blind study, either Vyvanse or placebo was given as an add-on therapy for patients who hadn't responded fully to Forest Laboratories' antidepressant Lexapro. Patients using Vyvanse did see more improvement in their symptoms than placebo patients did, but the difference wasn't statistically significant.
Still, Shire apparently believes that Vyvanse can meet the approval threshold for depression therapy; it says it expects to start depression trials of the drug in mid-2011. There could be plenty of payoff if the drug makes it, because antidepressants are among the biggest-selling drugs on the market. However, it will have to compete with other depression add-ons such as AstraZeneca's Seroquel.
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