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FDA Approves Paroxetine for the Treatment of Premenstrual Dysphoric Disorder

Philadelphia, PA, September 2, 2003 - GlaxoSmithKline today announced the US Food and Drug Administration (FDA) approved Paxil CR (paroxetine HCl) Controlled-Release Tablets as the first controlled-release medication for the treatment of premenstrual dysphoric disorder, a condition affecting three to eight percent of women of reproductive age in the United States. Premenstrual dysphoric disorder (PMDD) is characterised by intense emotional symptoms including irritability, tension, and depressed mood as well as physical symptoms associated with the menstrual cycle. Paxil CR is also indicated for the treatment of depression and panic disorder.

"As a clinician, I have seen first hand how debilitating PMDD can be for women in their lives and in their relationships with family, friends and co-workers," said Kimberly A. Yonkers, M.D., Associate Professor of Psychiatry, Yale University of Medicine and lead investigator of the largest clinical trial database of PMDD patients. "Today’s approval of Paxil CR provides physicians and patients with a new treatment option that effectively manages PMDD symptoms at the lowest available dose."

Premenstrual Dysphoric Disorder (PMDD)
Affecting over 5 million women of reproductive age in the US, PMDD is not just a new name for premenstrual syndrome (PMS). PMDD is a severe form of PMS that can significantly impair a woman’s ability to carry out daily activities both professionally and personally.

PMDD symptoms commonly emerge in the second half of the menstrual cycle and subside when menstruation begins or shortly thereafter. The symptoms follow this pattern every month or almost every month. Knowing PMDD symptoms is a critical element in the appropriate diagnosis and treatment of the condition. At least five of the following symptoms are required to diagnose PMDD, including at least one of the first four symptoms:

- Depressed mood
- Anxiety, tension
- Mood swings (feeling suddenly sad or tearful, increased sensitivity to rejection)
- Persistent, marked irritability, anger, increased conflicts
- Loss of interest in usual activities (work, school, socialising, etc.)
- Difficulty concentrating
- Fatigue, tiredness, loss of energy
- Marked appetite change, overeating, food cravings
- Insomnia (difficulty sleeping) or sleeping too much
- Feeling out of control or overwhelmed
- Physical symptoms such as weight gain, bloating, breast tenderness or swelling, headache, and muscle or joint aches and pains

"Literally millions of women suffer with the physical and emotional symptoms of PMDD, which often go undiagnosed and untreated. With the approval of Paxil CR for PMDD, we are pleased to offer a safe and effective FDA approved treatment option in a controlled-release formulation," said Bonnie S. Rossello, Vice President, Cardiovascular/Neuroscience, GlaxoSmithKline.

Paxil CR Relieves PMDD Symptoms in Clinical Trials
The tolerability and efficacy of Paxil CR (paroxetine HCl) Controlled-Release for the treatment of PMDD was established in placebo-controlled studies. In these studies, the lowest dose of Paxil CR, 12.5 mg per day, was significantly better than placebo in reducing the emotional and physical symptoms of PMDD. Similar results were seen with the 25 mg per day dose. Patients reported significant improvements in social functioning. Compared with women on placebo, patients taking Paxil CR reported fewer symptoms that interfered with regular daily activities.

Controlled-Release Paxil Tablets
Paxil CR (paroxetine HCl) offers the proven efficacy of paroxetine in a Geomatrix oral drug delivery system. The tablet is a multi-layered formulation that controls dissolution and absorption of the drug in the body. Paxil CR offers flexible dosing, and is available in three dosing strengths: 12.5 mg, 25 mg, and 37.5 mg. Geomatrix technology is licensed from SkyePharma PLC. Paxil CR is under review at FDA for social anxiety disorder and for the intermittent dosing for PMDD. For more information on Paxil CR log on to

About Paxil CR
Most common adverse events (incidence of 5 per cent or greater and incidence for Paxil CR and at least twice that for placebo) in studies for major depressive disorder, panic disorder and PMDD include infection, trauma, nausea, diarrhea, dry mouth, constipation, decreased appetite, somnolence, dizziness, decreased libido, tremor, yawn, sweating, abnormal vision, asthenia, insomnia, 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.

Source: GlaxoSmithKline

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