Being a paranoid schizophrenic, I am waiting with baited breath along with many others for any news about the next anticipated "blockbuster" drug Zeldox from Pfizer.
Some history: On July 19, 2000 the FDA advisory panel approved Zeldox nine to one. I thought it would be a matter of weeks until it was approved. I find out now, months later, that the FDA doesn't move that fast. Pfizer received an "approvable" letter with steps that it should take for an FDA approval on September 8, 2000. As of this writing, Pfizer and the FDA are in labeling discussions right now. Pfizer wants a good label without a "black box" warning of cardiac risk that the FDA may impose.
To do a little background research for this article, my first stop was the FDA's website at www.fda.gov and clicked the "search" box on the main page. It then allowed me to search their whole site for any news about Zeldox. I got seven hits. One of the seven hits was the actual document in pdf format that Pfizer submitted to the FDA for renewal. After reading this document I was impressed with what a good drug Zeldox seemed to be. So, it seemed that Zeldox would be a good move for me. My next question was, "When will Zeldox come out?" So I checked Dow Jones Interactive at the Science and Industry Business Library at 34th and Madison in Manhattan. From that vast databank of business knowledge I learned that Zeldox is being held up by labeling issues and would probably be hitting the markets early in 2001. It shouldn't be too long before I could get my hands on some Zeldox.
To keep the picture balanced I thought I'd do some more research on the Web. I came up with some interesting statistics. "... patients in the ziprasidone group were less likely to relapse after 52 weeks as compared with those in the placebo group. Approximately 70 percent of placebo users relapsed, only between 30-40 percent of the ziprasidone [Zeldox] users did (source: www.pslgroup.com/dg/131696.htm). I couldn't believe that. That sounded like a pretty high relapse rate to me. Here's another interesting statistic: with good management the current relapse rate is about 9% (source: www.mcg.edu/Resources/MH/sourcebk/sect2.html). I don't know where these people are getting their statistics, but 9% versus 30% seemed to be a relatively large discrepancy. I guess even though Pfizer is saying Zeldox is a good drug it's best to be cautiously optimistic. I had some second thoughts, but I think with my psychiatrist's approval I'd be one of the first in line!