The long-term goal of this research is to minimize morbidity due to non-adherence to outpatient antipsychotic-antimanic therapy.  Most psychotic and manic-depressive disorders require long-term maintenance treatment, in which reliable and sustained adherence to therapy is a major clinical challenge and limitation to therapeutic effectiveness.  Long-term adherence to antipsychotic treatment can be enhanced with long-acting, injectable preparations.  The only such agents licensed in the U.S. currently are long-chain fatty acid esters of the older neuroleptics fluphenazine and haloperidol, which carry a high risk of adverse extrapyramidal neurological effects, including tardive dyskinesia, and a sustained release formulation of risperidone incorporated into carbohydrate microspheres, which has recently been approved for twice-monthly injection.

Based on the clear clinical need and market opportunity, we have developed a formulation of olanzapine, one of the most versatile and clinically used anti-psychotic-antimanic agents.  This preparation promises to support twice-monthly administration of olanzapine.  We believe that the development of an injectable, sustained-release olanzapine is readily achievable and that it will become a useful tool in the outpatient treatment of individuals with highly prevalent major mental disorders including schizophrenia and manic-depressive illness, which together affect several percent of the general population at any time.