Shooting in the dark

FDA's Psychopharmacologic Drugs Advisory Committee voted unanimously last week that Zyprexa long-acting injection from Eli Lilly and Co. is effective and concurred the drug is safe - under certain circumstances - for both acute and maintenance treatment of schizophrenia. The panel carefully considered the agency's concerns about the occurrence of injection-related "excessive sedation," but in the end concluded that the added benefit of the long-acting formulation outweighed the risks.

Neither FDA nor the committee questioned the efficacy of Zyprexa LAI. Oral Zyprexa olanzapine, a selective monoaminergic antagonist, was first approved in 1996. The LAI depot formulation combines olanzapine and a pharmacologically inactive pamoate salt. ...