U.S. FDA staff cites sedation concern with Lilly drug

By Lisa Richwine

WASHINGTON (Reuters) - Excessive sedation is a serious concern following injections of a long-acting form of Eli Lilly and Co's Zyprexa schizophrenia medicine, U.S. drug reviewers said in an analysis released on Monday.

The experimental formulation, called Zyprexa Adhera, was shown to be effective for acute and long-term treatment of schizophrenia, U.S. Food and Drug Administration staff said.

The agency will ask an advisory panel that meets Wednesday if it finds the formulation effective and "acceptably safe."

"Excessive sedation events are a serious safety concern because of the severity of excessive sedation, the unpredictable characteristics, and relatively high incidence," FDA staff said in a preliminary analysis prepared for the panel meeting.

The rate was about 1.3 percent of patients, or 24 out of 1,915 who were treated with the drug, the FDA analysis said.

Lilly said the formulation provided important benefits that outweighed the sedation risk.

Zyprexa is Lilly's top-selling drug with nearly $4.8 billion in 2007 sales. The company currently sells it in pill form and as a short-acting injection.

The long-acting form could reach $1 billion in annual sales if approved, Natixis Bleichroeder analyst Jon LeCroy said.