Phase III data on Brisdelle published in Menopause-Noven Pharma

Noven Pharmaceuticals has announced the publication of data on the effects of Brisdelle (paroxetine) capsules, 7.5 mg, in the October 2014 issue of Menopause. The article presents exploratory analyses from pooled results that measured the impact of Brisdelle on weight and sexual function within two, double-blind, randomized, placebo-controlled Phase III trials of women with moderate to severe vasomotor symptoms (VMS), commonly referred to as hot flashes.

At the onset of these studies almost 60% of participants reported sexual dysfunction based on the ASEX. The proportion of participants reporting sexual dysfunction in the Brisdelle group compared to placebo at 4 weeks was 56% in both arms, 55% vs 52% at week 12, and 56% vs 57% at week 24, respectively. HFRDIS subscore results were also analyzed and the difference between Brisdelle and placebo trended similarly. The analyses showed that the frequency of treatment-emergent sexual dysfunction and weight change from baseline were similar between Brisdelle and placebo.

As noted in the article, there are limitations to these analyses and it is unknown whether either might appear as an adverse event with longer term therapy. See: "Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause," David Portman et al. Menopause, Vol 21 No 10 October 2014