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Msg  2079 of 3189  at  4/9/2018 12:24:27 PM  by

biotech2k


 In response to msg 2077 by  spaddy
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Re: From the horses mouth

 That is my I say, "Manage the risks and the winner take care of themselves." Right now ACAD certainly has risk. I can't say with 100% certainty that this whole article is rubbish. I know the trial data. It did have higher deaths. It wasn't enough to stop the FDA. They had data in phase 2 for ADP which had no elevated deaths.
 
 In the -019 Study, pimavanserin was generally well tolerated and the safety profile was consistent with what has been observed in previous studies. Based on a preliminary analysis of safety data, the most common adverse events reported were falls, urinary tract infection and agitation. The mortality rate was the same in the pimavanserin and placebo treatment groups. The mean age of patients in the study was 86 years.
 
The overall data suggest that Nuplazid isn't any worse then placebo by much in a highly frail elderly patient population. The FDA gave Nuplazid breakthrough therapy after seeing the -019 data in ADP. They would not do that if they had any concerns about deaths. It is also not any worse then the rest of anitpsychotics they use for this indication off label. 
 
 The warning was prompted by a review of 17 placebo-controlled studies with 5,106 elderly patients on antipsychotics over a period of about 10 weeks. Study results showed that elderly patients who took Risperdal had a risk of death that was 1.7 times higher than those who took placebo. The specific causes of death varied from patient to patient but were primarily related to cardiovascular causes such as heart failure or heart attack and infections such as pneumonia.


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