MIAMI & NEW YORK--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that it has completed the Phase 3 clinical development program evaluating low-dose mesylate salt of paroxetine (LDMP) for the treatment of vasomotor symptoms (VMS) associated with menopause (hot flashes). The Phase 3 clinical program was comprised of two studies involving an aggregate of 1,180 subjects from more than 130 centers across the U.S. “As next steps, we are scheduling a pre-NDA meeting with the FDA, and expect to submit our NDA for LDMP in 2012.” The first Phase 3 study was a 24 week, multi-center, double-blind, randomized,...
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