FDA Approves Lexapro as Newest Antidepressant
By Bruce Sylvester
HealthScoutNews Reporter
THURSDAY, Aug. 15 (HealthScoutNews) -- From one
antidepressant a more powerful one has sprung.
The U.S. Food and Drug Administration (FDA)
today approved the drug
Lexapro as a treatment for major depression. Interestingly, this latest
entry into the antidepressant market resulted from a molecular re-engineering
of the popular
antidepressant Celexa.
Lexapro (escitalopram) is the first
antidepressant to get the FDA's nod since Celexa (citalopram) won approval four
years ago. Both are made by Forest Laboratories of New York City and both are
SSRIs (selective serotonin reuptake inhibitors) like their
cousins Prozac, Zoloft and Paxil.
"Lexapro is a more potent version of
Celexa, in that the component that
fights depression has
been isolated," says Talia Puzantian, a clinical pharmacist in psychiatry
at San Francisco General Hospital.
This means patients will only need 10
milligrams to 20 milligrams a day of Lexapro, half of what is generally used
with Celexa, Puzantian adds.
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 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," says Andrew Farah, a psychiatrist and medical
director of High Point Regional Hospital in High Point, N.C. "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 adds.
Farah notes the decision was driven by Howard
Soloman, chief executive officer 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, mot notably in a
Business Week cover story in May.
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 says.
Three European and U.S. studies presented at
the Anxiety Disorders Association of America annual meeting in March 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 four women and one in 10 men
in the United States will be diagnosed with depression during their lifetime.
The World Health Organization 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.
NOTE: Business Week has more on
Howard and Andrew Solomon's story.
Other Recent Lexapro Stories
For comprehensive information on depression,
visit the HealthyPlace.com Depression Center. On
HealthyPlace.com Radio, we've done several shows on depression. Listen to them
in our 2002 and
2001 archives.
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