Phase 3 Study Update of Low-Dose Paroxetine Mesylate for Menopausal Vasomotor Symptoms

Noven Pharmaceuticals announced results from two multicenter, double-blind, randomized, placebo-controlled Phase 3 clinical studies evaluating low-dose mesylate salt of paroxetine (LDMP) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

A 24-week study of LDMP evaluated weekly reductions in the frequency and severity of moderate to severe VMS in 568 women age ≥40 with an average of more than 7–8 moderate to severe hot flashes daily or 50–60 moderate to severe hot flashes per week for at least 30 days prior to the study. Women who met eligibility criteria were randomized to receive either 7.5mg of LDMP or placebo once daily at bedtime for 24 weeks.

At Week 4, women taking LDMP had a mean weekly reduction from baseline of 28.9 fewer hot flashes, compared to a mean weekly reduction from baseline of 19 fewer hot flashes for placebo-treated patients (P<0.0001). At Week 12, women taking LDMP had a mean weekly reduction from baseline of 37.2 fewer hot flashes, compared to a mean weekly reduction from baseline of 27.6 fewer hot flashes for placebo-treated patients (P=0.0001). Results also showed that mean weekly reductions in VMS severity were also significantly greater for LDMP than for placebo at Week 4 (–0.089 and –0.056, respectively; P=0.0452) and at Week 12 (–0.123 and –0.067, respectively; P=0.0114). Mean weekly reductions in VMS hot flash composite scores (moderate and severe) from baseline were significantly greater for LDMP than placebo at Week 4 (–76.08 and –49.5 respectively; P<0.0001) and at Week 12 (–97.73 and –70.2 respectively; P=0.0001).

A 12-week study of LDMP evaluated weekly reductions in the frequency and severity of moderate to severe VMS in 606 women age ≥40 with an average of more than 7–8 moderate to severe hot flashes daily or 50–60 moderate to severe hot flashes per week for at least 30 days prior to the study. Women who met eligibility criteria were randomized to receive either 7.5mg of LDMP or placebo once daily at bedtime for 12 weeks.

At Week 4, women taking LDMP had a mean weekly reduction from baseline of 33 fewer hot flashes, compared to a mean weekly reduction from baseline of 23.5 fewer hot flashes for placebo-treated patients (P<0.0001). At Week 12, women taking LDMP had a mean weekly reduction from baseline of 43.5 fewer hot flashes, compared to a mean weekly reduction from baseline of 37.3 fewer hot flashes for placebo-treated patients (P=0.009). Results also showed that mean weekly reductions in VMS severity from baseline were significantly greater for LDMP than placebo at Week 4 (–0.09 and –0.05, respectively; P=0.0048) but not at Week 12 (–0.1 and –0.09, respectively; P=0.2893). Mean weekly reductions in VMS hot flash composite scores (moderate and severe) from baseline were significantly greater for LDMP than placebo at Week 4 (–85.51 and –60.83 respectively; P<0.0001) and at Week 12 (–111.9 and –96.85 respectively; P=0.0063).

LDMP is a non-hormonal treatment option being clinically developed for the treatment of women who suffer from vasomotor symptoms, but who are not candidates for, or who have concerns about, hormone therapy. Paroxetine is a selective serotonin reuptake inhibitor.

For more information call (800) 455-8070 or visit www.noven.com.