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Re: SaphrisTM(Asenapine)- new hope or all the same » mike1975

Posted by jrbecker76 on November 24, 2008, at 22:20:06

In reply to Asenapine - new hope or all the same, posted by mike1975 on November 24, 2008, at 19:27:58

> Hi guys,
>
> What do you think of this new anti-psychotic?
>
> http://www.marketwatch.com/news/story/Schering-Plough-Unveils-Top-Line/story.aspx?guid=%7B2B848E13-A93F-49A7-A221-BC61F162DD46%7D
>
> Take care
>
> Mike

Mike-

Louis,

It looks like the FDA will have to finish its big hiring initiative before they'll be able to stick to getting anything approved according to their original PDUFA timelines. Hopefully, the agency will give a ruling on Saphris (Asenapine)in the next couple of months.

Asenapine, at least on paper, looks like a pretty interesting profile....many have hyped it as the next AP blockbuster. It will probably be a little activating like Ziprasidone, and leave very little incidence of hyperprolatictinemia and weight gain. By its high affinity for 5-HT2C, it will be a good candidate to impact negative symptoms. It's weakness as a stand-alone AP though might be that it's not that sedating (i.e., won't fulfill a role like Seroquel does to address sleep as well as other symptoms...although this profile might be in fact a positive attribute for many); and secondly, it needs twice daily dosing. Also, the drug's original co-developer, Pfizer, dropped out after Ph III studies were complete. You have to wonder why. But still, it looks to be pretty interesting.

Click here for a topline PPT review:
akzonobel-ccna.com/misc/downloadabledoc.asp?tp=0&id=vWmL7JQ22j0%3D&number=1&l=English


JB


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