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Sertraline HCl Approved For Long-Term Use.(Brief Article)
2001 SEP 20 - (NewsRx.com & NewsRx.net) --
Pfizer, Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval for long-term use of Zoloft (sertraline HCl) in the treatment of post-traumatic stress disorder (PTSD).
The new label for Zoloft indicates it is safe and effective in preventing relapse of PTSD and in sustaining symptom improvement over 28 weeks in both men and women.
The FDA granted the label change following review of the first-ever placebo-controlled study to examine the efficacy and tolerability of long-term pharmacotherapy of PTSD. Zoloft is currently the only medication approved for PTSD and is the most prescribed brand in the U.S. for the treatment of mood and anxiety disorders.
"This new study shows that patients can be maintained on Zoloft over the long-term which is very significant given the high rate of relapse in PTSD patients and the fact that the average duration of the illness is at least several years," said Cathryn M. Clary, MD, Pfizer. "Prior studies with Zoloft demonstrated the safety and efficacy of the product in the acute and continuation phases of treatment."
Post-traumatic stress disorder is a common psychiatric disorder, with prevalence rates higher than diabetes and asthma. In the U.S., one out of 13 individuals will experience PTSD at some point in their lives following exposure to an extreme traumatic event. The most common traumas associated with a risk for PTSD include experiencing sexual or physical assault, a ...
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