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

-therapy with ACP-103 also provided a significantly faster onset of antipsychotic action. After only two weeks of therapy, about 50% more patients in the ACP-103/risperidone arm responded to treatment compared to each of the risperidone LD (p less than 0.008) and risperidone HD (p less than 0.03) arms. A responder was defined as a patient showing at least a 20% reduction in the PANSS.

Importantly, patients in the ACP-103/risperidone co-therapy arm also had 50% less gain in weight than patients in the risperidone HD arm. This difference trended to statistical significance (p=0.078).

The study also evaluated ACP-103 as a co-therapy with haloperidol. The ACP-103/haloperidol arm showed a 21.6 point (25.6%) improvement in the PANSS as measured after day 42 compared to baseline (p less than 0.0001), a primary endpoint in the study. The haloperidol arm showed a robust antipsychotic effect and there was no statistical difference compared to the ACP-103/haloperidol arm after day 42. However, the ACP-103/haloperidol arm did appear to result in a faster onset of antipsychotic action after only two weeks of treatment as compared to the haloperidol arm. In addition, patients in the ACP-103/haloperidol co-therapy arm had less gain in weight compared to patients in the haloperidol arm. -0-

Study Arms                                  Baseline Mean   Percentage
Mean     Change  Change
----------------------------------------------------------------------
ACP-103 (20 mg) plus haloperidol (2 mg)     85.6     -21.6  25.6%
----------------------------------------------------------------------
Haloperidol (2 mg) plus placebo             86.4     -25.1  29.2%
----------------------------------------------------------------------
Data based on the PANSS using the Intent to Treat Population and Last
Observation Carried Forward Methodology.

Each of the treatments was generally safe and well tolerated. Adverse events were comparable among the five study arms
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