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INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalized Patients
Date:10/13/2007

disorganized thoughts and uncontrolled hostility/excitement, than quetiapine (p < less than or equal to > 0.008) and placebo (p < less than or equal to > 0.003) at two weeks. In the additive therapy phase (days 15-42), 52.9 percent of patients taking INVEGA received optional additive therapy compared with 55.4 percent of patients taking SEROQUEL.

Discontinuation rates due to adverse events were: INVEGA (4%), SEROQUEL (10%) and placebo (6%). In the monotherapy phase, adverse events that occurred with an incidence of < greater than > 10 percent were headache (INVEGA 12%, SEROQUEL 8% and placebo 14%), somnolence (9%, 12%, 1%), tremor (14%, 5%, 8%), and insomnia (10%, 9%, 11%). In the additive therapy phase, adverse events that occurred with an incidence of < greater than > 10% were headache (INVEGA 14%, SEROQUEL 12% and placebo 16%), hypertonia (12%, 4%, 4%), sedation (4%, 11%, 4%), somnolence (11%, 15%, 3%), tremor (20%, 8%, 15%), dizziness (4%, 15%, 1%), schizophrenia (6%, 9%, 13%) and insomnia (12%, 10%, 15%).

During the study, 8 percent of the INVEGA patients reported a serious adverse event (SAE), compared to 4 percent of SEROQUEL patients and 3 percent of patients on placebo. The only SAE reported in more than two percent of patients was schizophrenia (INVEGA 4%, SEROQUEL 2%, and placebo 0%).

Ortho-McNeil Janssen Scientific Affairs, LLC and Johnson & Johnson Pharmaceutical Research & Development, LLC sponsored this clinical study. Additional details about the study are available upon request.

INVEGA, an atypical antipsychotic medication, was first approved in the U.S. in December 2006. It is approved for the acute and maintenance treatment of schizophrenia in the U.S. and for the treatment of schizophrenia in the E.U.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently 2 million people with schizophrenia, with men an
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SOURCE Janssen, L.P. and Johnson & Johnson
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