Shire is calling is SPD503. I read the name of it will be Connexyn. It was submitted to FDA August 2006 and had to go for a 10 month trial. So that is June 2007. I'm not usre if that is when it is due to come out. There is quite a bit of data on it if you search.
This is a good link, it also talks about their other new stimulant product coming out even later this year, that sounds promising also!
The ten months is the expected review period (how long it takes the FDA to look at all the submitted clinical data, manufacturing information, etc.-many thousands of pages). Once the FDA approves the med (if they have no further questions), then they work with the company on the appropriate labelling (this includes the package insert, doctor information, patient info and advertising). Then marketing starts.Thx! Just a little light reading!For those of you whose kids have taken gaunfacine only for a week or more, what type of activities were they able to partcipate in successfully while on guanfacine only? We are thinking of giving our dd guanfacine only for the summer and are trying to make summer plans. The past 2 summers we have given her a break from stims. Without any meds at all she really cannot particpate in camps or much at all for that matter. I am trying to figure out if she could do a day camp or even a sports camp on guanfacine only. I know some of you have experience with this. How do your kids do with sports and or structured settings? She has more of the hyper/impulsive issues but focus can be a problem too. I am wondering if she would be able to focus on sports without a stimulant and only on guanfacine???
Thanks so much in advance for your help and advice!!!!
My youngest was on guanfacine alone for 6 weeks for a trial. It covered, hyperactivity, defiance, impulsivity and some (though not enough) focus at school. It took 6 weeks for use to realize she really needed the stimulant to fully focus at school because her grades had only dropped to Bs (which was fine) and behavior was unchanged from the combo of stim and guanfacine. She did fine in kung foo and with playing with friends.
We plan on stopping the stim for the summer and staying with just the guanfacine after this experience. My youngest gets 2mg AM, 2mg at night and some days a 1/2mg booster for socially challenging evenings.
Because they are all different, you would have to try it out. In the shire studies, focus was also helped in the majority of subjects, so it is worth the trial. The trick is to make sure it is in the system for all the activities (given 3x a day for most kids for best results). It is effective for ADHD for 6-8 hours even though it is has a longer half life (12-18 hours).
Thanks so much for that information Vickie! I wish that Shire's extended release version would get approval soon. I think the FDA has until mid June to review the application. We are difinitely taking her off stimulants for the summer so I figure the guanfacine alone would be preferable to no meds at all. We shall see. Her psychiatrist has been very reluctant to try her on it and I can't figure out why! SHe seems to be just the type that guanfacine would help.
Thanks again!!