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.
For more information call (800) 455-8070 or visit www.noven.com.