Long-Acting Formulation of Zyprexa to Get Advisory Committee Review

The FDA’s Psychopharmacologic Drugs Advisory Committee will consider the safety profile of a long-acting injectible formulation of Eli Lilly’s atypical antipsychotic Zyprexa for the treatment of schizophrenia.

The drug, Zyprexa Adhera (olanzapine pamoate depot), is designed as an intramuscular injection that can be administered once every two or four weeks, Lilly said. An injectible formulation of Zyprexa is approved as a rapid-acting medication for those with agitation related to schizophrenia and bipolar I mania.

The FDA said a particular safety concern that should be addressed at the meeting relates to the occurrence of severe somnolence. The meeting is scheduled for Feb. 6, 2008.

Lilly said the safety and efficacy profiles of the long-acting injectable and table formulations are similar.