Doesnt SEPR own a piece of ACAD? Cant find the reference ...
ACADIA Announces Positive Results From ACP-103 Phase II Schizophrenia Co-Therapy Trial
-- Enhanced Antipsychotic Efficacy --
-- Faster Onset of Action --
-- Less Weight Gain --
-- Conference Call Scheduled for Today, March 19, 2007, at 9:00 a.m. Eastern Time --
ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD) today announced positive top-line results from its Phase II schizophrenia co-therapy trial with ACP-103, ACADIA’s proprietary and selective 5-HT2A inverse agonist. The trial evaluated ACP-103 co-therapy when used together with either risperidone, a commonly prescribed atypical antipsychotic drug, or haloperidol, a generic typical antipsychotic drug. The co-therapy arms with ACP-103 demonstrated statistically significant antipsychotic efficacy as measured by the reduction in the Positive and Negative Syndrome Scale (PANSS), the primary endpoint of the trial. In addition, the co-therapy arm combining ACP-103 with low-dose risperidone demonstrated a statistically significant improvement in antipsychotic efficacy as compared to low-dose risperidone plus placebo, and comparable efficacy to high-dose risperidone plus placebo. Co-therapy with ACP-103 also led to a faster onset of antipsychotic action and an improved side effect profile.
“These data clearly demonstrate the advantages of co-therapy with ACP-103 and show the importance of 5-HT2A receptor antagonism in schizophrenia therapy,” said Herbert Y. Meltzer, M.D., Professor of Psychiatry and Pharmacology and Director of the Psychosis Program at the Vanderbilt University School of Medicine. “Current antipsychotic agents used to treat schizophrenia and related neuropsychiatric disorders have many dose-related limitations. The use of ACP-103 in co-therapy with risperidone or other modern atypical antipsychotics may result in enhanced efficacy and an improved side effect profile, suggesting a formula for a new and improved treatment paradigm for patients with schizophrenia.”
Trial Design
The Phase II clinical trial was a multi-center, randomized, double-blind, placebo-controlled, six-week study designed to evaluate the ability of ACP-103, when used together with either 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<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. |
