April 14

Placebo Beat Both Zyprexa & Eli Lilly’s Experimental Drug

Reuters reported that the results of an Eli Lilly controlled clinical trial comparing the company’s experimental antipsychotic (mGIu2/3), against its FDA-approved blockbuster drug, Zyprexa, show that the PLACEBO PERFORMED BETTER than EITHER of Lilly’s antipsychotics.

Lilly acknowledged that three patients on the experimental drug "experienced convulsions."

…"patients given a placebo demonstrated a response that was about double that historically seen in clinical trials with patients suffering from schizophrenia."

Lilly attempted to spin the embarrassing results, claiming the trial was "inconclusive." 

The company resorted to the scientifically untenable claim that Zyprexa is "known to be more effective…."

"neither its experimental drug, known as mGlu2/3, nor its antipsychotic Zyprexa –known to be more effective than a placebo — performed better than the placebo….patients given a placebo demonstrated a response that was about double that historically seen in clinical trials with patients suffering from schizophrenia."

The company claim and the experimental drug was "generally well tolerated…" is belied by  three patients who had convulsions!

posted by Vera Hassner Sharav

Reuters–Dallas News
Eli Lilly schizophrenia drug trial inconclusive
Sun Mar 29, 2009

* Lilly calls schizophrenia drug study inconclusive
* Says placebo response was double usual response
* Says to continue development of drug

NEW YORK, March 29 (Reuters) – Eli Lilly and Co  Research <http://www.reuters.com/stocks/researchReports?symbol=LLY.N> said on Sunday it will initiate another mid-stage trial to study an experimental schizophrenia drug after results from its initial Phase II trial were inconclusive.

The drugmaker said inconclusive trial results are common in the field of neuroscience, and that it will continue developing the drug with an additional Phase II study.

In its study, Eli Lilly said patients given a placebo demonstrated a response that was about double that historically seen in clinical trials with patients suffering from schizophrenia.

Therefore, neither its experimental drug, known as mGlu2/3, nor its antipsychotic Zyprexa — known to be more effective than a placebo — performed better than the placebo.

Lilly said the experimental drug was generally well-tolerated, though three patients experienced convulsions. It also said the experimental drug had a low association with adverse events commonly associated with currently available antipsychotics, such as weight gain. (Reporting by Martinne Geller, editing by Maureen Bavdek)

© Thomson Reuters 2009. All rights reserved.

Thomson Reuters journalists are subject to an Editorial Handbook which requires fair presentation and disclosure of relevant interests.

 

 

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