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Back To Vidyya FDA Approves Zyprexa® For Long-Term Therapy Of Schizophrenia

First Atypical Antipsychotic Agent in US to Receive Indication

ELi Lilly and Company announced today that the US Food and Drug Administration has approved Zyprexa® (olanzapine) for long-term therapy and maintenance of treatment response of schizophrenia. Zyprexa is the first of the newer generation of antipsychotics, known as "atypicals," to prove its long-term effectiveness in these populations.

Schizophrenia is a brain disorder often characterized by acute episodes of delusions (false beliefs that cannot be corrected by reason), and hallucinations (usually in the form of non-existent voices) and long-term impairments such as diminished emotion, lack of interest and depressive signs and symptoms.

Approximately 2.5 million Americans, ages 18-25 have schizophrenia, and more than 100,000 new cases are reported each year.

"Zyprexa demonstrated robust efficacy and long-term safety in the study comparing it with placebo in the maintenance of treatment response in schizophrenia," said Alan Breier, M.D., Research Fellow and Leader, Zyprexa Product Team, Lilly Research Laboratories. "In fact, the results of the study were so strong, we were ethically bound to the early termination of the study to limit unnecessary patient exposure to placebo."

Placebo-treated patients were almost 10 times as likely to relapse over a six-month period compared to the Zyprexa-treated patients. The six-month cumulative relapse rate for Zyprexa was statistically superior to placebo (6% versus a placebo rate of 55%, p<.0001).

"Schizophrenia is a lifelong illness requiring lifelong treatment," said Ralph Aquila, M.D., Director, Residential Community Services, Saint Luke's- Roosevelt Hospital Center. "I can't overestimate the value of a medication with proven long-term efficacy and safety, because it can prevent the need to switch medications. It's best to keep a patient on one medication for as long as possible, because treatment changes can often lead to symptom relapse." Relapse can also occur when patients no longer respond to medication, fail to take their medication as prescribed, are under more stress than usual, do not get enough rest, drink alcohol or use street drugs. Patients experiencing relapse have described feeling nervous or afraid, having trouble sleeping, hearing voices in their head getting louder, and feeling like they are slipping back into their illness.

The FDA's approval of Zyprexa as the first atypical antipsychotic in the US to receive an indication for maintenance of treatment response of schizophrenia was based on results of a double-blind placebo-controlled discontinuation study of 326 clinically stable outpatients with few or no symptoms for at least six weeks. They received oral Zyprexa therapy for another six weeks followed by an eight-week observation period to confirm stability.

Following the observation period, 224 patients were randomized to Zyprexa (10-20 mg/day) and 102 patients were randomized to placebo. There were 177 patients with schizophrenia (79%) and 47 with schizoaffective disorder (21%) in the Zyprexa group. There were 89 patients with schizophrenia (87.3%) and 13 with schizoaffective disorder (12.7%) receiving placebo.

"Zyprexa-treated patients were significantly less likely to discontinue treatment as a result of either an adverse event or because of lack of efficacy," Dr. Breier said. "The Zyprexa treated group also improved on all quality of life measures while those on placebo worsened. We found that Zyprexa was safe and generally well-tolerated at doses of 10, 15 or 20 mg/day."

The label change for maintenance of treatment response in patients with schizophrenia is the second new indication received for Zyprexa in the United States this year. On March 17, the FDA approved Zyprexa for marketing for the short-term treatment of acute manic episodes associated with bipolar disorder.

Zyprexa is indicated in the United States for the treatment of schizophrenia. It is also approved for the short-term treatment of acute manic episodes associated with bipolar disorder. Since Zyprexa was introduced in 1996, it has been prescribed to more than 5 million people worldwide.

In the original schizophrenia registration trials, Zyprexa was generally well tolerated. However, as with all medications, Zyprexa was associated with some side effects. In the original six-week, acute-phase schizophrenia trials, the most common treatment-emergent adverse event associated with Zyprexa was somnolence. Other common events were dizziness, weight gain, constipation, akathisia (restlessness) and postural hypotension. Modest elevations of prolactin were also seen, although mean changes from baseline to endpoint were not statistically significantly different between Zyprexa and placebo. A small number of patients experienced asymptomatic elevations of hepatic transaminase; none of these patients developed jaundice or drug- induced hepatitis.

In short-term (3- and 4-week) acute bipolar mania trials, the most common treatment-emergent adverse event associated with Zyprexa was somnolence. Other common events were dry mouth, dizziness, asthenia, constipation, dyspepsia, increased appetite and tremor.

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Editor: Susan K. Boyer, RN
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