Studies Show Lowest Dose Paxil CR(TM) Reduced Physical and Emotional Symptoms of Premenstrual Dysphoric Disorder

Market Wire, 20050229

Analysis of three placebo-controlled studies, presented this week at the 156th annual American Psychiatric Association meeting in San Francisco, CA, demonstrate that Paxil CR(TM) (paroxetine HCl) Controlled Release is effective in treating the emotional symptoms of premenstrual dysphoric disorder (PMDD), including irritability, tension and depressed mood, as well as the associated physical symptoms. The lowest dose of Paxil CR, 12.5 mg per day, was shown to reduce overall symptoms and was well-tolerated with a low rate of patient drop outs. Similar results were seen with 25 mg per day dose. Paxil CR is currently under review by the U.S. Food and Drug Administration as a treatment for PMDD.

Premenstrual dysphoric disorder is a condition associated with severe emotional and physical symptoms that are linked closely to the menstrual cycle. Symptoms occur regularly in the second half of the cycle and end when menstruation begins or shortly thereafter, and can be so severe that they significantly impair a woman's ability to carry out daily activities. Studies have found that 5 percent of menstruating women have PMDD.

"For years many women have suffered with extreme premenstrual symptoms, unable to get relief from over-the-counter remedies," stated author Kimberly A. Yonkers, M.D., Associate Professor of Psychiatry, Yale University of Medicine. "Now that we have data from the largest clinical trial database of PMDD patients, women and their physicians have a new treatment option. The lowest dose of Paxil CR has been shown to provide relief across the total range of symptoms, and is well-tolerated with a low rate of patient drop outs."

Paxil CR Provides Significant Symptom Relief

Data from three multicenter, double-blind, placebo-controlled, fixed-dose studies of Paxil CR(TM) (paroxetine HCl) Controlled Release in treating PMDD were evaluated. Across all studies, 1,030 patients were randomized to receive Paxil CR at either 12.5 mg per day, or 25 mg per day, or placebo, for up to three cycles. Each study had as its primary endpoint a composite of visual analog items that measured emotional symptoms such as irritability, tension, affective lability, and depressed mood. Secondary endpoints included physical symptoms (for example, breast tenderness or swelling, headache and bloating) as well as measures of occupational and social functioning.

At both doses, patients taking Paxil CR experienced significantly greater reduction in both emotional and physical symptoms, compared to patients on placebo. This difference began with treatment cycle one and continued throughout the studies.

"Women who believe they may have PMDD should talk to their physician to discuss treatment options, like Paxil CR," added Dr. Yonkers.

Additional Data Highlight Paxil CR Efficacy in PMDD

Two additional abstracts presented at the annual meeting of the American Psychiatric Association provide further evidence that Paxil CR can treat the overall symptoms of PMDD. In this multi-center study, 366 women were randomized to receive 12.5 mg or 25 mg per day of Paxil CR or placebo during the luteal phase (last 14 days) of the menstrual cycle. In one study, patients receiving 12.5 mg or 25 mg per day of Paxil CR dosed intermittently reported significantly superior improvement in the emotional symptoms of PMDD, compared to women taking placebo. The primary endpoint for this study was change from baseline in the mean score on a composite measure of emotional symptoms, called the VAS-Mood Score. Both doses of Paxil CR were superior to placebo in reducing the average VAS-Mood Score, and were well-tolerated.

Asecond abstract presented at the meeting described continued symptom improvement, in those patients treated for up to six months with Paxil CR. In this study, Paxil CR 12.5 mg per day and 25 mg per day produced relief in the emotional symptoms of PMDD for over the six months of the trial, and were well-tolerated.

About Paxil CR

Paxil CR(TM) (paroxetine HCl) Controlled Release is approved by the U.S. Food and Drug Administration for the treatment of major depressive disorder and panic disorder. Most common adverse events (incidence of 5% or greater and incidence for Paxil CR and at least twice that for placebo) in studies for major depressive disorder and panic disorder include infection, trauma, nausea, diarrhea, dry mouth, constipation, decreased appetite, somnolence, dizziness, decreased libido, tremor, yawning, sweating, abnormal vision, abnormal ejaculation, female genital disorders and impotence. Patients should not be abruptly discontinued from antidepressant medication, including Paxil CR. Concomitant use of Paxil CR in patients taking monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated.

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