Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause

Eligible subjects will be entered into a 1-week observation period followed by a 1-week
run-in period. Following completion of the run-in period, eligible subjects will be
randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a
1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment
questionnaires will be administered at baseline and at Day 28 and Day 57 visits.

Inclusion Criteria:

1. Female, >40 years of age

2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60
moderate to severe hot flashes per week for at least 30 days prior

3. Spontaneous amenorrhea for at least 12 consecutive months

4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause

5. Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy

Exclusion Criteria:

1. History of hypersensitivity or adverse reaction to paroxetine mesylate

2. Use of an investigational study medication within 30 days prior to screening or
during the study

3. Concurrent participation in another clinical trial or previous participation in this
trial

4. Family of investigational-site staff