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FDA Approves Intermittent Dosing of Paroxetine for Premenstrual Dysphoric Disorder

PHILADELPHIA, Feb. 24 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK - News) today announced the U.S. Food and Drug Administration (FDA) approved the company's Supplemental New Drug Application (SNDA) for an intermittent dosing regimen of Paxil CR(TM) (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, the first and only controlled-release SSRI indicated for intermittent treatment of PMDD, 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."

Paxil CR Relieves PMDD Symptoms in Both Continuous and Intermittent Dosing

Clinical Trials
The tolerability and efficacy of intermittent dosing with Paxil CR(TM) (paroxetine HCl) Controlled-Release Tablets 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.

"We are pleased to provide physicians the option of offering their patients a choice in their dosing schedule with Paxil CR, the first controlled-release treatment for premenstrual dysphoric disorder," said Bonnie S. Rossello, Vice President, Cardiovascular/ Neuroscience, GlaxoSmithKline. "Women taking Paxil CR have the flexibility and convenience of effectively managing the emotional and physical symptoms of PMDD at a low dose, whether it is taken for two weeks or the entire month."

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

Controlled-Release Paxil Tablets
Paxil CR(TM) (paroxetine HCl) Controlled-Release Tablets 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 with three dosing strengths: 12.5 mg, 25 mg and 37.5 mg. Geomatrix technology is licensed from SkyePharma PLC (Nasdaq: SKYE/LSE:SKP). Most common adverse events (incidence of 5% or greater and incidence for Paxil CR at least twice that for placebo) in studies for major depressive disorder, panic disorder, PMDD and social anxiety disorder include infection, trauma, nausea, diarrhea, dry mouth, constipation, decreased appetite, somnolence, dizziness, decreased libido, tremor, yawning, 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.

For more information on Paxil CR log on to www.paxilcr.com, or for patients who are being treated with Paxil CR, visit CRBalance.com.

Source: GlaxoSmithKline

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