To: Anthony Wong who wrote (8221 ) 10/7/1999 8:52:00 PM From: Anthony Wong Read Replies (1) | Respond to of 9523
FDA panel to review new use for Pfizer's Zoloft Updated 10:58 AM ET October 7, 1999 By Lisa Richwine WASHINGTON (Reuters) - A federal advisory panel on Friday is set to consider whether the government should give its blessing to another use for Pfizer Inc's Zoloft, one of the top-selling drugs in the booming antidepressant market. Pfizer has asked the U.S. Food and Drug Administration to make Zoloft the first approved drug to treat post-traumatic stress disorder, which experts say afflicts about 5 percent of Americans. First approved in 1992, Zoloft is battling Eli Lilly and Co.'s popular pill Prozac, SmithKline Beecham's Paxil and other antidepressants. Zoloft is now approved for treating depression, obsessive-compulsive disorder and panic disorder. On Friday, an FDA advisory panel is to review new company studies on the drug's safety and effectiveness in people with post-traumatic stress disorder. Panelists are expected to vote on whether to recommend approval to the FDA, which usually follows its panels' advice. Doctors already prescribe Zoloft for post-traumatic stress, experts said. Winning the new indication would give Pfizer more freedom in marketing the drug but would spur only a tiny boost from the current sales pace, analysts said. Zoloft's second-quarter sales were $461 million, eclipsed by market-leader Prozac with $561.8 million. "Obviously Pfizer is doing a good job to promote the product," said Southeast Research Partners analyst Le Anne Zhao. But "any additional indication will help." Post-traumatic stress disorder can occur after a serious, life-changing event, such as a natural disaster, military combat, a rape or beating, or a serious car accident. The condition hits women twice as often as men, usually starting with nightmares or flashbacks, said Jerilyn Ross, president of the Anxiety Disorders Association of America. Patients can become withdrawn, have trouble sleeping or become startled easily, Ross said. Known generically as sertraline hydrochloride, Zoloft is in the class of drugs known as selective serotonin reuptake inhibitors (SSRIs), which dominate antidepressant sales. Makers of competing SSRIs also are hoping to expand their approved uses, analysts said. The next may come for Prozac, which is set to be reviewed for premenstrual syndrome at an FDA advisory panel meeting Nov. 3. news.excite.com