Noven Pharmaceuticals announced positive top-line results from its Phase 2 study evaluating Mesafem (low-dose paroxetine mesylate) for the treatment of vasomotor symptoms (hot flashes) associated with menopause (VMS). This eight-week, multi-center, double-blind, randomized, placebo-controlled trial enrolled 102 patients (with 98 patients completing), where patients in the active arm received a dose of Mesafem below 10mg once daily. The primary outcome measures were mean changes in frequency and severity of moderate-to-severe hot flashes from baseline to the fourth and eighth weeks of the study. Safety and tolerability of Mesafem were similar to placebo, with no drug-related serious adverse events.

Mesafem is a non-hormonal treatment option being clinically developed for the treatment of women who suffer from VMS, but who are not candidates for, or who have concerns about, hormone therapy.

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