Phase 3 Trial Update of Low-Dose Paroxetine Mesylate for Menopausal Vasomotor Symptoms
Noven Pharmaceuticals announced that it has completed its 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 US.
The first Phase 3 trial was a 24 week, multi-center, double-blind, randomized, placebo-controlled efficacy and safety study. 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 first study were achieved with statistical significance.
The second Phase 3 trial, which received a Special Protocol Assessment (SPA) by the FDA, was a 12 week, multi-center, double-blind, randomized, placebo-controlled study. 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. All primary outcome measures in the second study were achieved with statistical significance, except for severity at week twelve, which did not reach statistical significance.
In accordance with the SPA, the second study included a responder analysis necessary to demonstrate the clinical meaningfulness of subject response. The first study also included a responder analysis, and in both studies the responder analysis endpoints were achieved with statistical significance.
LDMP 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.