Lower dose of Bayer's Angeliq approved by FDA
Thursday, March 01 2012 | Comments
The Food and Drug Administration
approved a lower dose formulation of Bayer HealthCare Pharmaceuticals Inc.
's Angeliq (drospirenone/estradiol) tablets.
The new formulation, which contains 0.25 mg of drospirenone and 0.5 mg of estradiol, is indicated to treat moderate to severe vasomotor symptoms associated with menopause in women who have a uterus.
The original formulation of Angeliq, which contains 0.5 mg of drospirenone and 1 mg of estradiol, is indicated for the treatment of moderate to severe vasomotor symptoms and for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause in women who have a uterus.
The efficacy of the lower-dose formulation in the approved indication was assessed in a randomized, double-blind trial that included 735 postmenopausal women aged 40 years or older. All of the women had at least seven or eight moderate to severe hot flashes per day or 50 to 60 moderate to severe hot flashes weekly. The study participants were randomized to receive the lower-dose formulation of Angeliq, the previously approved dose of Angeliq, estrogen monotherapy or placebo for 12 weeks.
As compared with the women who received placebo, those who received the lower dose of Angeliq achieved a statistically significant reduction in the frequency and severity of moderate to severe vasomotor symptoms at weeks four and 12. The mean difference in the daily reduction of frequency of hot flashes between low-dose Angeliq and placebo was a decrease of approximately two episodes per day at week four and a decrease of approximately three episodes per day at week 12, according to Bayer.