Yesterday Shire announced that a supplemental new drug application has been filed with the FDA. The reviewal process takes about 10 months. So maybe in a year it'll be approved. Pretty slow.

It's too bad they didn't initially have it approved, but I think it's simpler and easier to get a drug approved for their "strongest case", and then add on from there. Their strongest body of info would have been with pediatric ADHD since they have a larger pool of patients to recruit for studies and it's widely accepted to treat kids with stims.

There are fewer adults with ADHD and a very small proportion of all with ADHD to want to participate in a study (since adults work and don't have parents helping out to organize everything). They must have been working on adult trials during the past year.

Oh well, at least they realized the need... just would have been nice for them to have done some heavy recruiting to make those trials happen along with the pediatric trials.

Darn, that's too bad. I like the concept of Vyvanse, particularly the idea of a declining efficacy as the dose increases to help prevent abuse.