Thursday, February 7, 2008

Lilly's Monthly Zyprexa Causes Sleepiness, FDA Says (Update3)

Eli Lilly & Co's once-a-month version of its top-selling antipsychotic medicine Zyprexa, while effective, has risks that include excessive sleepiness, U.S. regulators said.

People with schizophrenia taking a monthly injection instead of daily tablets already on the market may experience ``profound sedation,'' staff of the Food and Drug Administration said in documents posted today on the agency's Web site. The sleepiness is a ``serious safety concern'' because of its severity and ``relatively high'' incidence, the FDA said.

An FDA advisory panel meets Feb. 6 to consider whether Lilly should be allowed to sell the monthly Zyprexa. Sales of Zyprexa tablets, also used to treat bipolar disorder, rose 9 percent to $4.76 billion last year, accounting for about a quarter of Indianapolis-based Lilly's revenue. The drugmaker is investing in new and reformulated products because the original Zyprexa may face generic competition as early as 2011.

``There's a huge demand,'' said Jeffrey Lieberman, the chairman of psychiatry at Columbia University in New York in a telephone interview. ``Even though this is a long-acting form of an existing drug, it's a significant event for the simple reason that the biggest trouble with treating people with antipsychotics is adherence to treatment.''

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