Pimavanserin is in phase 3 for the adjunctive treatment of schizophrenia, and phase 2 for the treatment of negative symptoms.
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The phase 3 trial in sz is expected to wrap up in Jan 2019.
Isn’t that the drug that had a lot of deaths in clinical trials compared to placebo?
They did have a 2x higher death rate in at least one trial in Parkinson’s in the high dose group. But as far as I know the reasons for the deaths didn’t point to a particular mechanism that would explain why those patients died, that is whether it was related to the drug. I wasn’t able to find anything definitive on why the FDA was eventually satisfied and approved the drug and allowed further trials. Maybe there were other trials that didn’t have higher death rates, I’ll see if I can find any.
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@everhopeful this was the most informative article I found.
It will be interesting to see what the rates of adverse events were in the Alzheimer’s trial.
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Here we go @everhopeful, I found a table of serious adverse events for the Alzheimer’s trial.
Now these are very unwell old folks. But it looks like the rate of deaths and serious adverse events were not significantly different between groups.
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Lol.
We’ll have to see what they find. I remember 10-20 years ago everyone was convinced silicone breast implants caused any number of disorders. But it ended up, probably not.
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