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Clinical Trials

Paxil CR (paroxetine hydrochloride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved February 2002

Specific Treatments:

Depression, panic disorder

General Information

Paxil CR, a controlled-release tablet, is approved for the treatment of panic disorder. Paxil CR was previously approved in March 1999 as a treatment for major depressive disorder.

Depression affects close to 20 million Americans and is the most common serious brain disease in the United States. A major depressive episode is defined as experiencing five of the following depressive symptoms within a two week period: persistent sad mood, diminished interest in previously enjoyable activities, changes in weight or appetite, difficulty sleeping, agitation, fatigue, feelings of worthlessness or guilt, impaired concentration and suicidal thoughts.

In a given year, panic disorder affects approximately 2.5 million Americans between the ages of 18 and 54. Half of those inflicted develop the condition prior to age 24 and women are twice as likely as men to be diagnosed. Panic disorder is characterized by unexpected and repeated attacks of intense fear in combination with four of the following symptoms: chest pain, heart palpitations, sweating, trembling, shortness of breath, a choking sensation, nausea, dizziness, distortions of reality, fear of losing control, fear of dying, numbness and chills or hot flashes.

Clinical Results

Approval of Paxil CR is supported by results from two placebo-controlled studies with subjects diagnosed with major depressive disorder and three flexible-dose studies with subjects with panic disorder. Paxil CR was shown to be significantly more effective than placebo in all studies except the third study for treatment of panic disorder.

Side Effects

Adverse events associated with the use of Paxil CR may include (but are not limited to) the following:

  • Abnormal ejaculation
  • Abnormal vision
  • Constipation
  • Somnolence
  • Decreased libido
  • Sweating
  • Female genital disorders

Mechanism of Action

Paxil CR (paroexetine hydrochloride) is a selective serotonin reuptake inhibitor with a chemical structure unrelated to that of other such drugs. The effectiveness of Paxil CR in the treatment of depression and panic disorder seems to be linked to potentiation of serotonergic activity in the central nervous system resulting from the inhibition of neuronal uptake of serotonin.

Additional Information

For additional information on Paxil CR, please visit GlaxoSmithKline.

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