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 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 Psychopharmacologic Drugs Advisory Committee met on 6 February 2008. They 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.
In this case, the Psychopharmacologic Drugs Advisory Committee met on 6 February 2008. They 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.
Brain & Behavior
Medicine & Health
Comments
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.
Posted by: stumpy | February 7, 2008 1:47 PM
"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.
Posted by: Daniel Newby | February 7, 2008 9:55 PM