FDA staff members remain neutral on approval of new Zyprexa formula.
In continuing coverage from yesterday's briefing, MedPage Today (2/6, Gever) reports that Food and Drug Administration (FDA) staff members "took a neutral posture on whether agency advisers should recommend" Zyprexa's (olanzapine) "new [depot] formulation for schizophrenia." Currently, the drug "is approved as a daily oral pill or intramuscular injection for patients with schizophrenia or bipolar
disorder." The "depot formulation is intended to be delivered every two to four weeks," and drugmaker Eli "Lilly plans to market it as an alternative for patients who have trouble with the daily dosage forms." While "[a]n FDA staff memo to the committee said clinical data Lilly had submitted on the depot formulation shows that it is effective for both acute and maintenance treatment of schizophrenia," the memo also expressed concern about "an adverse event that appears to be unique for this formulation of olanzapine -- instances of sometimes profound sedation occurring shortly after an injection." The FDA's Psychopharmacologic Drugs Advisory Committee will meet on Wednesday to decide whether or not to approve the formula.
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