Brisdelle (low-dose paroxetine mesylate)

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

Approval Status:

Approved July 2013

Specific Treatments:

vasomotor symptoms of menopause

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General Information

Brisdelle is a low-dose formulation of paroxetine mesylate, a selective serotonin reuptake inhibitor. It is not an estrogen, and its mechanism of action for the treatment of VMS is unknown.

Brisdelle is specifically indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

Brisdelle is supplied as a capsule for oral administration. The recommended dose is 7.5 mg once daily, cat bedtime, with or without food.

Clinical Results

FDA Approval
The FDA approval of Brisdelle was based on two phase III studies in 1174 postmenopausal women with a minimum of 7-8 moderate to severe vasomotor symptoms per day at baseline for 30 days prior to receiving study drug. Brisdelle was administered at a dose of 7.5 mg once daily at bedtime. Study 1 was a 12-week, randomized, double-blind, placebo-controlled clinical trial with a total of 606 postmenopausal women. Study 2 was a 24-week, randomized, double-blind, placebo-controlled clinical trial with a total of 568 postmenopausal women. The co-primary efficacy endpoints for both studies were the reduction from baseline in VMS frequency and severity at Weeks 4 and 12. Data from Study 1 showed a statistically significant reduction from baseline in the frequency of moderate to severe vasomotor symptoms at Week 4 and Week 12 and a statistically significant reduction in the severity of moderate to severe VMS at Week 4 for Brisdelle compared to placebo. Data from Study 2 showed a statistically significant reduction from baseline in the frequency and severity of moderate to severe vasomotor symptoms at Week 4 and Week 12 for Brisdelle compared to placebo.

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Side Effects

Adverse events associated with the use of Brisdelle may include, but are not limited to, the following:

  • headache
  • fatigue
  • nausea/vomiting

Mechanism of Action

Brisdelle is a low-dose formulation of paroxetine mesylate, a selective serotonin reuptake inhibitor. It is not an estrogen, and its mechanism of action for the treatment of VMS is unknown.

Additional Information

For additional information regarding Brisdelle or vasomotor symptoms of menopause, please visit the Brisdelle web page.