Here is Salmon's very well-educated take -- on the latest EU approval -- for the expanded indication of Bipolar Disorder I -- for Merck's asenapine, branded in the US as Saphris®, and in Europe as Sycrest® (and, more background; even more, on why Pfizer bailed on developing the drug, nearly 15 years ago):
. . . .This approval was to be expected and it was only a matter of time.
As for the AE profile you list these are mostly class effects and so are standard for any antipsychotic. The real issue is what is the difference in rates between drugs for which the data would only be available if AE data reported to FDA were to be made public.
The exception is suicide. Although there is an inherent risk in with the illness the data from the FDA AC package indicates that the primary risk comes from the drug and so this statement is really likely intended as misdirection.I personally doubt that the weak sales are due to the AE profile as it's little different from Zyprexa. Rather it's more likely due to it being a late entrant into a crowded field (Zyprexa, Seroquel, Risperdal, Invega, Geodon, Haldol, etc.) with drugs that are likely to go off patent soon.
I didn't have an opportunity to comment on the Mother Jones article you asked me to comment on, however he basically has it right. One thing he mentions is using all cause discontinuation rates and not breaking it out into specifics. This is an important point. There are statistical implications for this as well as implications of the lack of a placebo control the effect on the determination of adverse event profiles in addition to the efficacy implications the author mentions. Lastly of course is that it appears that a flexible which may level out all cause d/c rates (which were an inappropriate surrogate for efficacy as they could be due to AEs) yet would result in clearly different efficacy rates due to suboptimal doses with the competitor's products.
I will probably not comment too much in the future but will wait to see the court cases that ensue. . . .
Salmon
September 5, 2010 11:02 AM
As ever, we appreciate the able assist! Appear when you're able -- we are fortunate to have whatever time you can devote here. But feel no pressure, my friend. Do take joy, wherever the opportunity presents itself.
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