Furious Seasons

February 28, 2008

FDA Rejects Zyprexa Injectable

Well, I sure didn't see this coming, but it's just moving on the news wires that the FDA has decided not to approve the long-acting Zyprexa injectable called Adhera for use in schizophrenia.

"In its "not approvable" letter to Lilly, the U.S. Food and Drug Administration said it needed more information to better understand the risk and underlying cause of excessive sedation seen in about 1 percent of patients in clinical trials, the company said."

Interestingly, earlier this month the FDA's psychopharmacology advisory panel recommended that the FDA approve the drug but with extensive warnings included about sedation. Clearly, the full FDA wants to know more.

And you'll know more when I know more.

Posted by Philip Dawdy at February 28, 2008 07:54 AM

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Comments

wow that is surprising, and good news.

Posted by: Stephany at February 28, 2008 09:24 AM

I am not a psychiatrist, but it seems to me like the market for this drug is minuscule to begin with. Given the side effects, it seems like the only reason ever to administer it is if the patient has medication compliance issues and Risperdal, Geodon, and all the typical antipsychotics that are presently available in injectable form don't work. Insofaras this decision will prevent psychiatrists from prescribing Adhera to patients who haven't tried the other, safer options, it sounds like the FDA did the right thing.

Posted by: Simon at February 28, 2008 02:13 PM

The over-sedation incidents included a few folks who went into comas, which is, you know, a pretty extreme "side effect". What should be surprising but isn't anymore sadly is that it was approved in the preliminary round at all.

Posted by: Alison Hymes at February 29, 2008 06:09 AM

Adhera. Where do they come up with these names??? Can you imagine anything more repugnant than a friggin' drug ADHERING to you? I can't.

Then there was the ever Orwellian Halcyon. Placidil.

These names are just soooo creepy. I can't believe anyone gets past them to take the stuff.

Sherry

Posted by: Sherry at March 3, 2008 08:00 AM