Setback For Eli Lilly Over Controversial Schizophrenia Drug

The drug is known generically as olanzapine, one of the first “atypical antipsychotics” or second-generation antipsychotic drugs on the market.

Eli Lilly & Co had hoped to bring a longer-acting formula of the antipsychotic, Zyprexa (olanzapine) to market, but the plans have been delayed. The Food and Drug Administration is withholding approval for the time being.

So far the agency has not asked for additional studies, but Eli Lilly has received a so-called “complete response” letter from the FDA, meaning the agency isn’t yet ready to grant approval.

"We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation of olanzapine will offer an important option for treating this devastating and chronic illness," said Dr. Todd Durell, associate medical director for U.S. neuroscience at Eli Lilly.

Zyprexa is a once-daily tablet that treats the symptoms of schizophrenia and bipolar disorder.  A longer-acting formula would be given by injection once every four weeks for patients who have trouble taking tablets.

One year ago, Lilly’s application for olanzapine was rejected by the FDA, after excessive sedation was observed in about one percent of patients in clinical trials.

Zyprexa Controversy   

Zyprexa is not without controversy.

• Last July, Eli Lilly agreed to pay up to half a billion dollars in order to settle 18,000 claims by patients who claimed they had developed diabetes or suffered a stroke while taking Lilly’s number one atypical antipsychotic, Zyprexa.
  
  
• By September, a federal district court judge granted a motion to unseal hundreds of confidential documents about Zyprexa, part of a class-action case filed by pension funds, labor unions and insurance companies seeking for reimbursement for millions allegedly overspent on Zyprexa. They contend the company knowingly withheld information regarding the drug’s side effects while marketing it for off-label use.
  
  
• Lilly applied to expand the drug for use by adolescents. Zyprexa is frequently given “off label” to children and teens to treat everything from behavioral problems, including aggression and defiance, to bipolar disorders.  A St. Petersburg Times investigation finds in Florida children prescribed antipsychotics have increased some 250 percent over the last seven years.
  

• In 2004, the American Diabetes Association found Zyprexa more dangerous a cause of diabetes and hyperglycemia than other atypicals because of Zyprexa’s propensity to cause weight gain.
  
  
• A recent study found, elderly patients who are given antipsychotic drugs, such as Zyprexa, are three times as likely to experience serious health problems or death within a month of use, compared to those patients not given the drugs, according to recent findings by Canadian researchers.
  
  
• In 2007, the Institute for Safe Medication Practices and the Division of Public Health Sciences, Wake Forest University School of Medicine, conducted a longitudinal Adverse Events Reporting System Review of the U.S. FDA's most dangerous drugs. The study found Zyprexa was the thirteenth deadliest drug in the study, with over 1,000 deaths attributed to its use over an eight year period.
  

With global sales in 2006 eclipsing $4.2 billion, Zyprexa is among Lilly’s top-selling drug and a major contributor to company profits. #