Phase III trials of Brisdelle published in Menopause
Results from two Phase III clinical studies of Brisdelle (paroxetine) capsules, from Noven Pharma, for the treatment of moderate to severe Vasomotor Symptoms (VMS) associated with Menopause, showed that mean weekly reductions in VMS frequency were significantly greater for Brisdelle than for placebo at Week 4 and at Week 12.
The most common adverse reactions, defined as those experienced by at least 2 percent of patients taking Brisdelle compared to placebo were headache (6.3 vs. 4.8 percent), fatigue/malaise/lethargy (4.9 vs. 2.8 percent) and nausea/vomiting (4.3 vs. 2.3 percent). The drug was approved by the FDA in June 2013.
Results were published in Menopause. See: "Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials." Simon, James et al. Menopause: October 2013, Volume 20, Issue 10, p 1027-1035 doi: 10.1097/GME.0b013e3182a66aa7
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