LDMP: Phase III data

Hisamitsu's Noven Pharmaceuticals Inc. subsidiary reported top-line data from a double-blind, U.S. Phase III trial in menopausal women showing that once-daily LDMP for 12 weeks met the co-primary endpoints of reducing the mean frequency and severity of moderate to severe hot flashes from baseline to week 4 vs. placebo. LDMP also met the co-primary endpoint of reducing the mean frequency of moderate to severe hot flashes from baseline to week 12 vs. placebo, but missed the severity endpoint at week 12. The most common adverse events were nasopharyngitis, upper respiratory tract infection, diarrhea, headache, nausea and fatigue. Noven has an SPA from FDA for the trial. ...