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August 15, 2002
By Bruce Sylvester, HealthScoutNews Reporter
THURSDAY, Aug. 15 (HealthScoutNews) -- The U.S. Food and Drug Administration (FDA) today approved the drug Lexapro (escitalopram) for the treatment for major depression. Lexapro resulted from a molecular re-engineering of the popular antidepressant Celexa (citalopram).
Lexapro is the first antidepressant to get the FDA's nod since Celexa won approval four years ago. Both are made by Forest Laboratories of New York City and are SSRI's (selective serotonin reuptake inhibitors) like Prozac, Zoloft and Paxil.
"Lexapro is a more potent version of Celexa, in that the component that fights depression has been isolated," said Talia Puzantian, a clinical pharmacist in psychiatry at San Francisco General Hospital and an assistant clinical professor at the University of California in San Francisco.
"This means we'll be seeing 10-20 mg/day used in treatment rather than the 20-40 mg/day that is currently generally used with Celexa," Puzantian added.
The Celexa molecule contains two "mirror" parts called isomers, but only one isomer helps fight depression. Researchers created Lexapro by removing the inactive isomer.
Celexa's patent does not run out until late 2005. However, the company decided to seek FDA approval for Lexapro and to market it as soon as possible.
"Forest is taking a successful 1.4 billion dollar-a-year drug, Celexa, out of active marketing three years before the patent expires," said Andrew Farah, a psychiatrist and medical director of High Point Regional Hospital in High Point, NC. "They are replacing it with a drug that is costing them more to make but for which they plan to charge less."
"Lexapro is stronger, starts working faster and appears to have a lower side-effect profile. They could have held off on Lexapro and made their billions off of Celexa first. But that isn't happening here, and the implications, especially in terms of potency, side-effects and costs, could be huge for patients," he added.
Farah noted that the decision was driven by Howard Soloman, CEO of Forest, whose son Andrew suffered from debilitating depression. The Solomans have publicly discussed the impact of the disease on their family life and on their business priorities, notably in a Business Week cover story that was published on May 27, 2002.
Andrew Soloman emerged from the worst of his depression after several months of treatment with Cipramil, the European version of Celexa. He wrote a book about his struggle with the disease, The Noonday Demon: An Atlas of Depression, which was published in June 2001 and won the National Book Award for nonfiction.
"This will probably be a successful business decision by Forest, but it wouldn't be happening at all if Howard Solomon hadn't gone to Europe in the mid-1990s, searched for a better drug for his son, found the European version of Celexa, licensed it for the U.S. market and introduced it here," Farah said.
Three European and U.S. studies presented in March 2002 at the Anxiety Disorders Association of America annual meeting also suggest that today's FDA approval could herald future indications for Lexapro.
A Duke University clinical study reported that, "Escitalopram (Lexapro) treatment significantly improved anxiety symptoms relative to placebo treatment. The reliable anti-anxiety effects of this new drug suggest that it should be useful in the treatment of generalized anxiety disorder."
A study conducted at the University Hospital of Vienna concluded, "Escitalopram (Lexapro) 10-20mg/day is effective and well-tolerated in the treatment of social anxiety disorder."
Finally, a University of California at San Diego study reported that, "Escitalopram (Lexapro) in comparison to placebo significantly reduced panic attack frequency and severity, anticipatory anxiety, and phobic avoidance, and significantly improved overall clinical status and quality of life. The results of this study suggest that escitalopram is efficacious and well-tolerated in the treatment of panic disorder."
Approximately 19 million adult Americans suffer from a depressive illness each year. One of every 4 women and 1 in 10 men in the United States will be diagnosed with depression during their lifetime. The World Health Organization ( news - web sites) predicts depression will become the leading cause of disability by the year 2020.
Forest Laboratories expects Lexapro to be available in pharmacies by Sept. 5.
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