Acadia's ACP-103 reduces restlessness in schizophrenia patients in phase 2 study

By Angela McDaniels

Seattle, Dec. 1 - Acadia Pharmaceuticals Inc. said results from a phase 2 study show that its small molecule drug candidate ACP-103 reduced haloperidol-induced akathisia, a debilitating side effect of antipsychotic drugs characterized by restlessness and an urge to move.

The double-blind, randomized, placebo-controlled phase 2 study included 30 patients with a clinical diagnosis of schizophrenia or schizoaffective disorder, who also experienced haloperidol-induced akathisia.

Fourteen received a once-daily oral administration of 60 mg of ACP-103 and 16 were administered a placebo over a five-day period. All continued to receive their pre-study dose of haloperidol.

ACP-103 significantly reduced objective akathisia and produced statistically significant improvements or statistical trends for subjective awareness of restlessness and subjective distress related to restlessness, as measured by the Barnes Akathisia Scale, the company said.

However, there were no statistically significant differences between ACP-103-treated and placebo-treated subjects for global clinical assessment of akathisia, the primary outcome measure of the study, which the company attributed to a large placebo response.

Also, there were no significant effects on positive or negative symptoms of schizophrenia, but Acadia expected this because of the short treatment duration.

ACP-103 was safe and well tolerated and no serious adverse events were reported in the study, the company said. There was no evidence of a pharmacokinetic interaction between haloperidol and ACP-103.

Acadia is conducting an additional phase 2 trial with up to 400 patients designed to evaluate the ability of ACP-103 to improve both the efficacy and safety profile of current antipsychotic drugs.

Schizophrenia is a chronic disabling mental illness characterized by disturbances such as hallucinations and delusions as well as a range of negative symptoms.

Despite the availability of a variety of current antipsychotic drugs with worldwide sales exceeding $14 billion, many symptoms associated with this disease are poorly addressed by existing therapies, the company said.

Acadia is a biopharmaceutical company based in San Diego, Calif., that develops treatments for central nervous system disorders.

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