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Positive Phase III Data Reported for Brisdelle (Paroxetine) in Treatment of Vasomotor Symptoms of Menopause
Positive data on the effects of low-dose mesylate salt of paroxetine (Brisdelle, Noven Pharmaceuticals) have been published in the October issue of Menopause.
The article presents exploratory analyses from pooled results that measured the effect of paroxetine 7.5 mg on weight and sexual function in two double-blind, randomized, placebo-controlled phase III trials of women with moderate-to-severe vasomotor symptoms (VMS), commonly referred to as “hot flashes.”
The analyses showed that the frequency of treatment-emergent sexual dysfunction and weight change from baseline were similar between paroxetine and placebo.
Brisdelle (paroxetine) 7.5 mg was approved by the FDA in June 2013 for the treatment of moderate-to-severe VMS associated with menopause. It is not approved to treat depression or any other psychiatric conditions.
Data collected in the 12-week and 24-week studies included changes in the body mass index (BMI) and weight, in the Arizona Sexual Experiences Scale (ASEX), and in the Hot Flash-Related Daily Interference Scale (HFRDIS) sexuality subscore, as well as adverse events (AEs) related to weight or sexual dysfunction. Results were assessed at week 4, week 12 (pooled data), and week 24 (24-week study).
The percentage change in median body weight from baseline to week 4 was 0% in the paroxetine arm and +0.21% in the placebo arm. The change from baseline in mean body weight was +0.17% with paroxetine and +0.52% with placebo at week 12, and was +0.48% with paroxetine and +0.09% with placebo at week 24.
At the start of the studies, almost 60% of the participants reported sexual dysfunction based on the ASEX. The proportion of participants reporting sexual dysfunction in the paroxetine group compared with placebo at 4 weeks was 56% in both arms; 55% vs. 52%, respectively, at week 12; and 56% vs. 57% at week 24. HFRDIS subscore results showed a similar trend.
The labeling for Brisdelle (paroxetine) 7.5 mg includes warnings and precautions similar to those of the higher doses of paroxetine used to treat a number of psychiatric disorders, including a boxed warning about suicidal thoughts or behaviors. The most common adverse reactions in paroxetine-treated patients compared with those given placebo included headache (6.3% vs. 4.8%, respectively), fatigue/malaise/lethargy (4.9% vs. 2.8%) and nausea/vomiting (4.3% vs. 2.3%).
Source: Noven Pharmaceuticals; October 14, 2014.