The Corpus Callosum

Zyprexa Adhera Nears Final Approval

Zyprexa Adhera is a new formulation of href="http://zyprexa.com/index.jsp">Eli LIlly’s
antipsychotic medication, href="http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601213.html">olanzapine.
 It contains the same active ingredient as the pills, but it
is a long-acting injection.  It is supposed to last two to
four weeks.

There is not a lot of specific information available yet.  It
is not on the market yet, either.  The milestone is that in
was just recommended for approval by the title="Food and Drug Administration"> href="http://www.fda.gov/">FDA.


Background: after a drug is developed, but before it is marketed, it
goes through a lengthy evaluation by the FDA.  Near the end of
this process, an expert panel meets to make a preliminary, nonbinding
recommendation.  Drugs that receive such a recommendation
usually are approved.

In this case, the href="http://www.fda.gov/cder/audiences/acspage/psychopharmroster1.htm">Psychopharmacologic
Drugs Advisory Committee href="http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24627.htm">met
on 6 February 2008.  They href="http://money.cnn.com/news/newsfeeds/articles/newstex/AFX-0013-22833349.htm">voted
10 to zero for approval.  Now it should be a matter of a few
months before the product receives final approval.  It
probably will be on pharmacy shelves shortly after that.  

What is it for?  First, let me say what it is not for.
 It is not for treatment of any kind of emergency situation.
 If a person with psychosis is seriously out of touch with
reality, and would benefit from rapid control of symptoms, Zyprexa
Adhera is not the drug to use.  Long-acting injectable
antipsychotic medication takes weeks or months to have any effect.
 

As a general rule, if a drug is given repeatedly, the amount of the
drug in the person’s bloodstream will increase with each successive
dose.  (That assumes the half-life is not a lot shorter than
the interval between doses.)  It takes about five half-lives
to reach a peak.

A drug that is intended to be given at intervals of two weeks would
have a very long half-life.  That means it would take a very
long time to reach a peak.  

For this reason, Zyprexa Adhera would not have any effect in an
emergent or urgent situation.  Rather, its intended use is for
persons with chronic psychosis who, for whatever reason, may not take
pills every day.  Naturally, it would be appropriate to use it
only when the expected benefit outweighs the risks.  That
calculation is a very individualized matter.  So much so, that
it would not be useful (or even meaningful) to make general
recommendation in a blog post.

Comments

  1. #1 stumpy
    February 7, 2008

    Say what you will about Eli Lilly’s products. The company knows a good name when their focus groups find one for them. First there was Strattera, which always makes me think of “steatorrhea”. Now we have “Adhera”, which sounds like something that came out of a Klingon’s nose in Star Trek. Gooey and sticky. I hope it’s not green colored.

  2. #2 Daniel Newby
    February 7, 2008

    “A drug that is intended to be given at intervals of two weeks would have a very long half-life. That means it would take a very long time to reach a peak.”

    Not quite. The drug molecule is the same as the oral formulation, so its metabolism and half-life (which RxList.com says is 30 hours) should be similar. Therefore it will reach steady state levels in the same time.

    The real issue is that a depot injection cannot be discontinued if bad side effects develop, which is why it will only be used for people who have already got the oral form working.

    Somewhere I read about an antipsychotic inhaler that is under development. Apparently IV sometimes isn’t fast enough.