Noven has reported positive top-line results from its phase 2 clinical study evaluating Mesafem (low-dose paroxetine mesylate). It is intended for the treatment of vasomotor symptoms (hot flashes) associated with menopause (VMS).
The study was multi-center, double-blind, randomized, placebo-controlled phase 2 efficacy and safety study of Mesafem in the treatment of VMS. The eight-week study enrolled 102 patients at ten clinical locations in the US. Patients in the active arm of the study received a dose of Mesafem below 10mg once daily.
The primary objective of the study was to assess the safety and efficacy of Mesafem for the treatment of VMS.
Peter Brandt, president and CEO of Noven, said: Today’s Phase 2 results exceeded all our internal expectations from the standpoints of both efficacy and tolerability. With the data from this study, we plan to expedite Mesafem into Phase 3 development, and to advance our commercialization and partnering strategies, with the goal of making this new non-hormonal treatment option broadly available to women who suffer from VMS, but who are not candidates for, or who have concerns about, hormone therapy.