Olanzapine: trouble for new injectable formulation

Federal regulators on Monday said a longer-lasting version of Eli Lilly's schizophrenia drug, Zyprexa (Olanzapine), appears effective, though a small number of patients experienced excessive sleepiness.The USFDA posted its review of Zyprexa Adhera ahead of a Wednesday panel meeting, where psychiatric drug advisers will vote on whether the drug is safe and effective. Zyprexa is currently available as a once-daily pill to treat schizophrenia and bipolar disorder. The new formulation is injected into the muscle and is designed to last two to four weeks. FDA will ask its outside experts to assess incidents of "profound sedation," seen in about one percent of patients injected with the drug. Most of the reports of sedation occurred one to three hours after injection. According to FDA, the side effect is unique to injectable Zyprexa and may require warning labeling to bring it to the attention of doctors and physicians. Based on draft questions posted to its Web site, FDA will ask its advisers whether the drug requires a "black box" warning, the most serious a drug can carry. For its part, Lilly said the sedation side effect is common to both traditional Zyprexa and the new version. According to a company analysis posted online Monday, there were "no differences in the incidence or timing of sedation" events between Zyprexa and Zyprexa Adhera. The company's scientists speculate that the drowsiness was caused by doctors incorrectly injecting the drug directly into the bloodstream, instead of into the muscle. Lilly said when the drug is injected appropriately it dissolves into the body over days and weeks, but when it is injected into the bloodstream it is absorbed over a few hours.