Eli Lilly and Company: Orally Disintegrating Zyprexa Zydis Reduces Acute or Breakthrough Symptoms of Schizophrenia; Multiple Dose Strengths Offer Options to Patients.

Business Editors/Health/Medical Writers

INDIANAPOLIS--(BUSINESS WIRE)--June 24, 2003

A new study suggests that acutely ill schizophrenia and schizoaffective disorder patients with a history of medication noncompliance may experience significant improvement in their symptoms and may demonstrate a significantly improved attitude toward taking medication when treated with Zyprexa(R) Zydis(R)(olanzapine orally disintegrating tablets). The study was published in the June issue of the International Journal of Neuropsychopharmacology.

"In my experience working with people with schizophrenia, Zyprexa Zydis provides dependable control of symptoms such as hallucinations, disruptive behavior and agitation," said Beth Baxter, M.D., medical director of the Park Centers in Nashville, Tenn., where she also practices as a psychiatrist. "The effective management of these breakthrough symptoms has helped many of my patients avoid hospitalization and the devastating consequences of relapse."

Zyprexa Zydis, an alternative formulation of Zyprexa , dissolves in the patient's mouth on contact with saliva. Zyprexa and its Zydis formulation are indicated for treatment of schizophrenia, maintenance of treatment response in schizophrenia, and treatment of acute manic episodes associated with bipolar I disorder.

Study Highlights

-- Patients showed improvement in overall symptom improvement as

measured by a significant reduction in the Positive and

Negative Syndrome Scale (PANSS) total score during the study

(p less than .001). At the end of the six-week study, 60

percent of patients achieved at least a 20 percent reduction

(the measure of clinical response) in a PANSS total score.

-- Significant improvement in clinical symptoms was also evident

when evaluated by the physician-rated Clinical Global

Impression (CGI) scale. CGI-improvement occurred as early as

the second day of treatment (p less than .001) and continued

throughout the study (p less than .001).

-- Using various rating scales, significant improvements in

medication compliance, attitude and nursing care burden were

observed.

-- Patient-rated feelings about the medication showed positive

acceptance at all measured time points, as indicated by

Patient Global Impression score.

-- In patients with schizophrenia or schizoaffective disorder,

the initial improvements in symptoms and medication

compliance, observed within the first week of treatment with

Zyprexa Zydis, were sustained throughout the six-week study in

patients who either continued on the orally disintegrating

tablets, or who were switched to standard oral tablets of

Zyprexa.

-- Treatment-emergent adverse events reported by at least 10

percent of patients during the study were agitation, anxiety,

dry mouth, headache, insomnia, somnolence, and weight gain.

"Since its introduction in 2000, Zyprexa Zydis has been prescribed more than 500,000 times to patients around the world," said Bruce J. Kinon, M.D., Medical Advisor, Lilly Research Laboratories. "Having a full range of available doses, physicians will be able to help those patients who are unable or unlikely to take oral medication, to be treated effectively during an acute phase of their illness."

Study Design

Eighty-five acutely ill people with schizophrenia (n=63) or schizoaffective disorder (n=22) who met medication noncompliance criteria, received open-label Zyprexa Zydis orally disintegrating tablets (10-20 mg/day) for up to six weeks in the single-arm study. During the first week of the study, all participants received study medication within a supervised program (i.e., inpatient unit, day hospital program, or group home). After the first week, patients were released from supervised care if clinically indicated.

All patients initially received Zyprexa Zydis at a dose of 10 mg/day. Dosage increases were allowed in 5 mg increments up to 20 mg/day. The first increase could occur as early as the third day of the study, with subsequent increases occurring on a weekly basis. If a physician felt that a patient had shown significant improvement in psychosis and medication compliance, then the physician could switch the patient from orally disintegrating Zyprexa Zydis tablets to standard Zyprexa oral tablets on a direct milligram-for-milligram basis after the first week. This switch was allowed to determine if patients who showed a positive response to the orally disintegrating tablets would subsequently adhere to treatment with standard oral tablets. Improvement in medication compliance was assessed using various rating scales to measure changes in psychopathology, medication-taking and compliance attitudes, and nursing care burden.

About Schizophrenia

Schizophrenia is a severe and debilitating psychosis often characterized by acute episodes of delusions (false beliefs that cannot be corrected by reason), 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. It is usually associated with a disruption in social and family relationships. Schizophrenia is the most common severe mental illness. There are as many as 50 million people with schizophrenia worldwide, more than 33 million of them in developing countries. Symptoms of schizophrenia usually begin to appear in the teenage years or early to mid-twenties.

Schizoaffective disorder is characterized by the presence of psychotic symptoms in the absence of mood changes for at least two weeks in a patient who has a mood disorder. A diagnosis of schizoaffective disorder is used when an individual does not fit diagnostic standards for either schizophrenia or mood disorders such as depression and bipolar disorder.

Zyprexa and Zyprexa Zydis Background

Zyprexa is indicated in the United States for the short- and long-term treatment of schizophrenia and for acute bipolar mania. Zyprexa is the first atypical antipsychotic to prove its long-term effectiveness in patients with schizophrenia. Since Zyprexa was introduced in 1996, it has been prescribed to 12 million people worldwide.

Zyprexa Zydis is available in multiple dose strengths or is available to cover the dose range of 5-20mg (5, 10, 15 and 20 mg), providing physicians with a dependable, orally disintegrating option even for acutely ill patients.

The most common treatment-emergent adverse event associated with Zyprexa in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonaggressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite, and tremor. A small number of patients experienced asymptomatic elevations of hepatic transaminase; none of these patients experienced jaundice.

Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia, seizures and orthostatic hypotension. Phenylketonurics should be advised that Zyprexa Zydis contains phenylalanine. Full prescribing information is available at www.zyprexa.com.

About Eli Lilly and Company 

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

Zyprexa(R)(olanzapine, Lilly)

Zydis(R) is a registered trademark of R.P. Scherer Corporation.