FDA Approves Paxil As New Treatment for PMDD
(Philadelphia, PA, September 2, 2003): A new treatment option is now
available for women who suffer from severe emotional and physical symptoms associated
with the menstrual cycle: the Food and Drug Administration (FDA) has approved Paxil CR™ (paroxetine HCl) Controlled-Release
Tablets for the treatment of premenstrual dysphoric disorder (PMDD), a condition
affecting three to eight percent of women of reproductive age in the United
States. 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. "[The] approval of Paxil CR provides physicians and patients
with a new treatment option that effectively manages PMDD symptoms at the lowest
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 for several days per
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
- Marked appetite change, overeating,
- 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. Paxil CR is currently under review at FDA
for the treatment of social anxiety disorder and for treatment with intermittent
dosing for PMDD.
About Paxil CR
Most common adverse events (incidence
of 5% 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.
For more information about PMDD, click here.
Click here for more information about depression or other mental
Created: 9/2/2003  - Donnica Moore, M.D.