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Positive Phase III Results Reported for Menopause Drug, Brisdelle (Paroxetine)

Product will be in pharmacies in November (September 18)

Menopause, the scientific journal of the North American Menopause Society, has reported positive results from two phase III clinical studies of Brisdelle (paroxetine, Noven Pharmaceuticals) in women with moderate-to-severe vasomotor symptoms (VMS) associated with menopause.

Brisdell (7.5 mg/day) was approved by the FDA for this indication in June 2013. The drug will be available in pharmacies beginning November 2013.

Menopause published the results from two double-blind, randomized, placebo-controlled phase III clinical studies. The subjects were treated for 12 weeks in one study, and for 24 weeks in the other study. The co-primary endpoints of both trials evaluated weekly reductions in the frequency and severity of VMS associated with menopause in patients taking Brisdelle versus placebo at week 4 and week 12. The persistence of treatment benefit was also evaluated at 24 weeks in the 24-week study.

In the 12-week trial, mean weekly reductions in VMS frequency were significantly greater for Brisdelle than for placebo at week 4 (–33.0 vs. –23.5, respectively; P < 0.0001) and at week 12 (–43.5 vs. –37.3, respectively; P = 0.0090). In the 24-week study, mean weekly reductions in VMS frequency were significantly greater for Brisdelle than for placebo at week 4 (–28.9 vs. –19.0, respectively; P < 0.0001) and at week 12 (–37.2 vs. –27.6, respectively; P = 0.0001).

In the 12-week trial, mean weekly reductions in VMS severity from baseline were significantly greater for Brisdelle than for placebo at week 4 (–0.09 vs. –0.05, respectively; P = 0.0048) but not at week 12 (–0.10 vs. –0.09, respectively; P = 0.2893). In the 24-week study, mean weekly reductions in VMS severity were significantly greater for Brisdelle than for placebo at week 4 (–0.09 vs. –0.06, respectively; P = 0.0452) and at week 12 (–0.12 vs. –0.07, respectively; P = 0.0114).

Brisdelle has 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.

Source: Noven Pharmaceuticals; September 18, 2013.

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