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New Treatment For Severe Emotional and Physical Symptoms of PMDD

Press Release

By Tracee Cornforth, About.com

Updated: September 3, 2003

About.com Health's Disease and Condition content is reviewed by the Medical Review Board

Philadelphia, PA, September 2, 2003 -- GlaxoSmithKline today announced the U.S. Food and Drug Administration (FDA) approved Paxil CR(TM) (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 characterized 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 U.S., 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, socializing, 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.
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