Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced top-line results from the first of two planned Phase 3 clinical studies evaluating low-dose mesylate salt of paroxetine (LDMP, formerly referred to as Mesafem) for the treatment of vasomotor symptoms (VMS) associated with menopause (hot flashes).
This first study, sponsored by Noven, was a 24 week, multi-center, double-blind, randomized, placebo-controlled Phase 3 efficacy and safety study of LDMP for the treatment of VMS associated with menopause. The primary objective of the study was to assess the safety and efficacy of LDMP for the treatment of menopausal VMS. The primary outcome measures were mean changes in frequency and severity of moderate-to-severe hot flashes from baseline to the fourth and twelfth weeks of the study, as well as maintenance of therapeutic effect at week 24.
All primary outcome measures in the study were achieved with statistical significance. The most frequent adverse events observed in the study were nasopharyngitis, upper respiratory tract infection, headache, nausea and fatigue.
A second, 12 week study of LDMP is underway. If that study meets its primary endpoints, Noven expects to submit a New Drug Application for LDMP to the U.S. Food & Drug Administration in 2012.
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