Intermittant Paxil dosing for PPMD?!?

February 25, 2004

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FDA Approves Intermittent Dosing of Paxil CR (Paroxetine) for Treatment Of

Premenstrual Dysphoric Disorder

New Two-Week Regimens Offer Flexibility and Convenience in Alleviating

Emotional and Physical Symptoms Of PMDD

PHILADELPHIA, PA -- February 24, 2004 -- GlaxoKline (NYSE: GSK) 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 CRª (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 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

(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,

GlaxoKline. " 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 (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 http://www.paxilcr.com, or for

patients who are being treated with Paxil CR, visit CRBalance.com.

SOURCE: GlaxoKline

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February 25, 2004