DrugBuyers.Com: Zoloft Gets U.S. OK for 'Social Phobia'

Pfizer's Zoloft Gets U.S. OK for 'Social Phobia'

Monday, February 10, 2003

NEW YORK Pfizer Inc. (PFE) on Monday said it had won permission from U.S. regulators to market its blockbuster depression drug Zoloft for additional use as a treatment for "social anxiety disorder."

People with the disorder often fear public speaking, acting in plays, playing musical instruments in public and eating in front of others, according to the Merck Manual of medical information -- situations that in an earlier era might have been characterized as shyness.

The New York-based company said Zoloft is the first member in its popular class of depression drugs, known as selective serotonin reuptake inhibitors (SSRIs), to win approval for long-term treatment of patients with the anxiety disorder.

It was also approved for acute, or short-term, treatment of the disorder, also known as social phobia. GlaxoSmithKline's (GSK.L) rival depression drug, Paxil, is already approved for acute episodes of the disorder.

Pfizer said people with social phobia experience "anxiety, fear and avoidance behaviors" in certain social situations.

Analysts have said its approved use for social phobia could help sustain or boost sales of Zoloft, which boasted fourth-quarter global revenues of $775 million. Pfizer said Zoloft is the most-prescribed SSRI in the United States. Other members of the class include Paxil and Eli Lilly's Prozac.

Social phobia is among many modern conditions, including attention deficit hyperactivity disorder, that some critics argue are often "medicalizations" of common human behavior for the purpose of selling more drugs.

But Pfizer spokesman Jeff Cook said social phobia is indeed a real condition that demands treatment.

"People suffering with social anxiety disorder are much more than shy. They experience significant emotional distress and sometimes even physical symptoms such as heart palpitations during common everyday activities that most people take for granted," Cook said.

Dr. Michael Liebowitz, a professor of clinical psychology at Columbia University and Pfizer consultant, estimated about 6 percent of the U.S. population during their lifetimes have social anxiety serious enough to qualify as social phobia.

"They have distressing or disabling anxiety or avoid most performance and social situations," Liebowitz said.

He said such people can be truly terrified of talking to a colleague or to a stranger on the telephone, or of asking for a date or going to a party.

"Many people are fearful in these situations, but people with social phobia can actually be crippled by such fears, to the point of becoming reclusive," Liebowitz said.