Earlier today, Dr. Tom Koestler offered some pablum, when asked about "what to expect" from the Asenapine July 30 review at FDA's Advisory Committee. [We will cover it on that day, of course.]
Well -- in response, and amplification, our very own (proprietary!) "Salmon" fillets it, thus (sorry!):
. . . .Of course what else would the PDAC focus on except manufacturing issues which they typically don't as they aren't qualified and it's taken care of in house.
As ever this should be interesting. As pointed out previously similar drugs seem to produce pulmonary arterial hypertension like phen-fen which is a long term complicaiton.
So the question becomes what long term comparative information allows you to assess if it's worse and have adequate studies been down to mitigate it.
The other problem seems to be hepatotoxicity.
Add on top of this that one of the two studies claimed to support efficacy in schizophrenia is a failed study (active control did not work) and there are other problems such that it's clear that it's not adequate or well controlled.
This gives us a high risk and low efficacy in schizophrenia.
As for bipolar even less risk should be tolerated as the lethality and severity of the illness is much less than for schizophrenia.Regardless of what FDA has published in the past, the law is absolutely clear that assessment of safety has to include expected off label use and with a sublingual formulation that will be used long term and especially in kids and the elderly regardless of what the label says means that it's likely asenapine can't meet the legal standard for approval. But of course that's not stopped FDA from approving drugs before. . . .
-- Salmon
Indeed.
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