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Paxil joins ranks of SSRIs for PMDD: controlled release.(News)
The controlled-release formulation of paroxetine was approved by the Food and Drug Administration for treating premenstrual dysphoric disorder, based on data in more than 1,000 women who met the DSM-IV criteria for the disorder.
This is the third drug (and the third selective serotonin reuptake inhibitor) approved for PMDD. Fluoxetine, marketed as Sarafem for this indication, and sertraline (Zoloft) have been approved previously. Both can be taken daffy throughout the cycle or during the luteal phase only.
The dosing schedule approved for controlled-release paroxerine, marketed as Paxil CE by GlaxoSmithKline, is a daily dose taken continuously throughout the cycle, but the company said that the intermittent dosing for PMDD is under review at the FDA. The recommended initial dose is 12.5 mg per day
In the trials, which together included 1,030 women with PMDD, those randomized to receive 12.5 mg or 25 mg per day for three menstrual cycles had statistically and clinically significant responses to treatment, compared with those who took a placebo.
One of the lead investigators, Dr. Kimberley Yonkers of the department of psychiatry at Yale University, New Haven, said that the treatment had a "robust" effect and that the lower dose was almost as ...
- FDA Approves Paxil CR(TM) for the Treatment of Premenstrual Dysphoric Disorder...
- Press release article from: PR Newswire September 2, 2003 700+ words
...physical and emotional symptoms of PMDD, which often go undiagnosed...the approval of Paxil CR for PMDD, we are pleased to offer a...treatment option in a controlled-release formulation," said Bonnie S. Rossello...GlaxoSmithKline. Paxil CR Relieves PMDD Symptoms in Clinical Trials...
- PMS, PMDD: Don't Mistake Them for Depression.
- Magazine article from: OB GYN News JOHNSON, KATE November 1, 1999 700+ words
...experts say. "Some people say that PMDD is the mood or affective component of a...University of Tennessee, Memphis. "With PMDD, there is more of an emphasis on the depression...literature about what constitutes PMS and PMDD and whether they are distinct entities...
- Does PMDD belong in the DSM? challenging the medicalization of women's bodies.
- Magazine article from: The Canadian Journal of Human Sexuality Offman, Alia Kleinplatz, Peggy J. March 22, 2004 700+ words
...prior to menses labelled as Premenstrual Dysphoric Disorder (PMDD), however, the research findings on PMDD have been tenuous. In this paper, the validity and utility of the PMDD diagnosis is" called into question and it is argued that PMDD...
- FDA Panel Agrees Fluoxetine Effective For PMDD.
- Magazine article from: OB GYN News MECHCATIE, ELIZABETH December 1, 1999 700+ words
...with premenstrual dysphoric disorder (PMDD). Their votes on efficacy, however...case, the three studies of fluoxetine for PMDD were investigator-initiated and sponsored...The company filed the application for the PMDD indication after the studies had been conducted...
- Premenstrual Syndrome (PMS) and Premenstrual Dysphoric Disorder (PMDD).(Adult...
- Clinical Reference Systems January 1, 2006 700+ words
...or PMS. Premenstrual dysphoric disorder (PMDD) is a severe, disabling form of PMS. Many...PMS. About 5% to 10% of these women have PMDD. How do they occur? The causes of PMS or PMDD are not yet clear. Some women may be more sensitive...
- Premenstrual Syndrome (PMS) and Premenstrual Dysphoric Disorder...
- Clinical Reference Systems January 1, 2002 700+ words
...and may be mild to severe. What is premenstrual dysphoric disorder (PMDD)? Premenstrual dysphoric disorder (PMDD) is a very severe form of premenstrual syndrome. PMDD includes severe physical, emotional, and quality-of-life problems...
- Premenstrual Syndrome (PMS) and Premenstrual Dysphoric Disorder...
- Clinical Reference Systems January 1, 2004 700+ words
...and may be mild to severe. What is premenstrual dysphoric disorder (PMDD)? Premenstrual dysphoric disorder (PMDD) is a very severe form of premenstrual syndrome. PMDD includes severe physical, emotional, and quality-of-life problems...
- Women Suffer Unnecessarily Due to Low Awareness of PMDD.(premenstrual dysphoric...
- Magazine article from: Women's Health Weekly December 21, 2000 700+ words
...term premenstrual dysphoric disorder (PMDD), a severe form of PMS, might cause...Awareness and Attitudes of Women Toward PMDD," conducted by Yankelovich Partners...have been have officially recognized as PMDD, let alone that such problems can be diagnosed...
