Called Sycrest in Europe, asenapine is proposed to be marketed under the trade-name Saphris here in the United States. The FDA has not set a date for its meeting on Saphris, yet. In any event, I expect erstwhile commenter Salmon will offer us some learned insights, and commentary, in the box, below -- and so, without further ado -- take it away, Salmon!
[Per the Forbes version of the Sycrest AP-carried release:]
. . . .Schering-Plough Corp. said Tuesday it asked regulators in the European Union to approve marketing of a schizophrenia drug called Sycrest. . . .
Paging Salmon. . . . your commentary on "second class treatments for schizophrenia and 'manic episodes associated with bipolar disorder' now requested -- STAT. . . ."
3 comments:
Thank you for the call out. I do have some idea as to why the EMEA application was filed at this time but I don't think it would be useful for me to go into why at this time.
What is interesting is that SP went the central route of the CHMP (Committee on Human Medicinal Products) of the EMEA (European Medicines Agency) rather than via a single country's regulatory agency acting as a rapporteur. This is right after the turn down last week of Seroquel's application in depression by the Dutch rapporteur necessitating an appeal to the CHMP. So it's likely they think there may be a better chance with the CHMP the question however is why would they think that?
The link you have to old posts of mine highlights a number of things, for example the potential for off-label use in kids.
Next week on June 9th and 10th there will be an FDA psychiatric drug advisory committee meeting on exactly the approvability of 3 differeent antipsychotics for bipolar disorder in children. Obviously any recommendation for approval will encourage prescribing of any and all antipsychotics in children (and especially sublingual forms such as asenapine). My feeling is that misleading information will be presented. What's interesting is that FDA is making the information on this meeting very difficult to find, even though it's very high profile it's as if they don't want anyone to really know about it.
In addition, notice that the link to my previous posts had indicates the death rate for 2 different antipsychotics is 1 in 80 people (and likely asenapine is similar or possibly even worse). Now add to this the recent news from the University of South Florida that the majority of use of antipsychotics in children is in those less than 12 years of age and in this age range it's use over 50% of the time is for ADHD or conduct disorder and for these 2indications over 35% of the time in older kids. In fact the use for bipolar isn't even listed. So almost all use is for things that they're no evidence of even any expectation of any efficacy. (unfortunateley I can no longer find a link but it's on page 22 of The Use of Antipsychotic
Medications with Children:
A Comprehensive and Current View
Robert J. Constantine, Ph.D.
Becky Larsen, MSPH
October 2007).
It's amazing to me the incredible use of highly lethal antipsychotic drugs (1 in 80 adults) which is often inappropriately forced on kids (13% of kids in foster care receive them) with NO scientific evidence for any expectation of benefit and based on data that I've seen there's actually evidence that would argue against any benefit.
Most people don't know this but the Food Drug and Cosmetics Act actually requires nonapproval of all of these antipsychotics when there's this kind of unsafe off-label use.
Plus as I've mentioned before abstracts published on asenapine indicate that there was only 1 postitive efficacy study in schizophrenia, whereas 2 is the regulatory standard.
Thus it simply amazes me how FDA could even consider asenapine to be approvable. In my opinion there is absolutely no way this could happen unless there is blatant corruption and illegal activity within the FDA.
Salmon
P.S. The 1 in 80 person death rate is for up to 1 year of use. After 1 year the rate probably increases just like with Vioxx. In fact I've heard Tom Laughren the head of the FDA psych division say the death rate due to antipsychotic drugs could be 10% with chronic use.
Salmon
I want to clarify my previous post that when I say
"NO scientific evidence for any expectation of benefit and based on data that I've seen there's actually evidence that would argue against any benefit."
I meant that the data I've seen argues against any benefit of antipsychotics in ADHD and I am not referring to other indications.
Salmon
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