Paroxetine approved for posttraumatic stress disorder


NEW YORK (Reuters Health) – GlaxoSmithKline Plc said on Friday that the US Food and Drug Administration has approved a posttraumatic stress disorder (PTSD) indication for the company's antidepressant paroxetine (Paxil).

Glaxo estimates that 16 million Americans are affected by PTSD, "a number which may rise in light of recent tragic events."

Pfizer's Zoloft (sertraline), the market-leading antidepressant, received a PTSD indication from the FDA in 1999 and this year won a broadened indication based on a 28-week study showing that it could prevent PTSD relapse and sustain symptom improvement.

But according to Glaxo, Paxil is the first approved medication to show efficacy in relieving all three of PTSD's major symptom clusters, which include reexperiencing the trauma, avoidance/numbing, and hyperarousal. Results of a trial funded by Glaxo and the National Institute of Mental Health and published in the American Journal of Psychiatry this month showed that PTSD patients given paroxetine did significantly better in all three areas than those given placebo. (See Reuters Health report, December 3, 2001.)

SmithKline Beecham submitted a supplemental new drug application requesting the PTSD indication in July 2000.

In addition to depression and PTSD, paroxetine it is approved for obsessive compulsive disorder, panic disorder, social anxiety disorder and generalized anxiety disorder, making it "the first and only medication indicated to treat depression and all of the major anxiety disorders," according to Glaxo.

Zoloft is indicated for depression, panic disorder with or without agoraphobia, obsessive compulsive disorder and PTSD.

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