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Acadia Announces Positive Results From ACP-103 Phase II,Schizophrenia Co-Therapy Trial

risperidone or haloperidol, to provide an improved therapy for patients with schizophrenia. The trial enrolled 423 patients across sites in both the United States and Brazil. Patients were randomly assigned to one of five study arms: ACP-103 plus low-dose risperidone (ACP-103/risperidone); low-dose risperidone plus placebo (risperidone LD); high-dose risperidone plus placebo (risperidone HD); ACP-103 plus haloperidol (ACP-103/haloperidol); or haloperidol plus placebo (haloperidol arm). The primary endpoint of the study was antipsychotic efficacy as measured after day 42 compared to baseline in each of the two ACP-103 co-therapy arms using the PANSS.

Trial Results

The ACP-103/risperidone co-therapy arm showed a 23.0 point (27.4%) improvement in the PANSS as measured after day 42 compared to baseline (p less than 0.0001), a primary endpoint in the study. In addition to meeting the primary endpoint, the ACP-103/risperidone arm demonstrated a statistically significant enhancement of antipsychotic efficacy as compared to the risperidone LD arm (p=0.01), and similar efficacy to the risperidone HD arm (p=NS). The significant efficacy enhancement over risperidone LD was observed for both positive and negative symptoms. -0-

Study Arms                                  Baseline Mean   Percentage
Mean     Change  Change
----------------------------------------------------------------------
ACP-103 (20 mg) plus low-dose risperidone
(2 mg)                                     84.8     -23.0  27.4%
----------------------------------------------------------------------
Low-dose risperidone (2 mg) plus placebo    87.5     -16.6  19.0%
----------------------------------------------------------------------
High-dose risperidone (6 mg) plus placebo   86.4     -23.2  26.4%
----------------------------------------------------------------------
Data based on the PANSS using the Intent to Treat Population and Last
Observation Carried Forward Methodology.

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