Supplemental approval for Paxil CR in treatment of premenstrual dysphoric disorder
Supplemental approval for Paxil CR in treatment of premenstrual dysphoric disorder
PHILADELPHIA, PA., February 24, 2004 -- GlaxoSmithKline announced that the FDA has approved the company's Supplemental New Drug Application (sNDA) for an intermittent dosing regimen of Paxil CR (paroxetine HCl) Controlled-Release Tablets for the treatment of premenstrual dysphoric disorder (PMDD).
With the new dosing option, women suffering from PMDD can take Paxil CR once-daily during the two-week period prior to the onset of their menstrual cycle rather than throughout the month. Paxil CR is also indicated for the continuous treatment of PMDD, depression, social anxiety disorder and panic disorder.
Affecting more than five million women of reproductive age in the U.S., PMDD is a severe form of PMS that can significantly impair a woman's ability to carry out daily activities. It is characterized by intense emotional symptoms including severely depressed mood, irritability and tension, as well as the debilitating physical symptoms associated with the menstrual cycle.
"In my experience, women like the flexibility of taking their medication during the two weeks they would normally experience the worst of their symptoms," 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. "The new dosing option with Paxil CR is appealing because patients can achieve relief from the debilitating physical and emotional symptoms of PMDD at a low dose and with a treatment schedule that suits their lifestyle."
The tolerability and efficacy of intermittent dosing with Paxil CR for the treatment of PMDD was established in a placebo-controlled study of 366 patients. In this study, the lowest dose of Paxil CR, 12.5 mg per day, given for the two weeks prior to the onset of menses (luteal phase dosing), was significantly more effective than placebo in reducing the emotional and physical symptoms of PMDD. Similar results were seen at 25 mg per day. Compared with women on placebo, patients taking Paxil CR reported fewer symptoms that interfered with regular daily activities.
Premenstrual Dysphoric Disorder (PMDD)
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. According to American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 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
For more information on Paxil CR, visit www.paxilcr.com. Patients who currently are being treated with Paxil CR should visit CRBalance.com
Source: GlaxoSmithKline
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