Synthelabo's Amisulpride Nears UK Approval

French pharmaceutical firm Synthelabo has received a favorable opinionfrom the UK's Committee on Safety of Medicines for its schizophrenia agent amisulpride. In addition, the company presented new data at the 6th World Congress on Biological Psychiatry in Nice, France, demonstrating that amisulpride is "at least as efficacious" as Janssen-Cilag's Risperdal (risperidone) in the treatment of the positive and negative symptoms of schizophrenia.

At low doses, amisulpride preferentially blocks presynaptic D2/D3 autoreceptors, increasing dopaminergic transmission, which may help explain its efficacy in alleviating primary negative symptoms, the firm points out. At high doses, the drug blocks postsynaptic D2/D3 receptors, particularly in the limbic system, which accounts for its efficacy in treating acute, positive symptoms of schizophrenia, it adds.

This dual action allows for dose modulation, ie when the patient is experiencing an acute phase of the disease the dose may be titrated, and then tapered off as this passes. The company adds that amisulpride's specificity for these receptors means that its use is not linked to hypotension, sedation, cognitive impairment, and gastrointestinal or urological side effects.