FDA approves lower dose Angeliq (Bayer HealthCare) for Menopause treatment

The FDA has approved a lower dose formulation of Angeliq (drospirenone and estradiol), from Bayer HealthCare, to treat moderate to severe vasomotor symptoms due to Menopause in women who have a uterus. The new formulation contains 0.25 mg drospirenone (drsp)/0.5 mg estradiol (E2) and will be available in the US by prescription shortly. The previously approved prescription formulation contains 0.5 mg drsp/1 mg E2 and is indicated for the treatment of moderate to severe vasomotor symptoms and treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to Menopause in women who have a uterus. The efficacy of low dose Angeliq for reducing the frequency and severity of moderate to severe vasomotor symptoms was evaluated in a randomized, double-blind, placebo-controlled trial with 735 postmenopausal women at least 40 years of age with a minimum of 7 to 8 moderate to severe hot flashes daily or 50 to 60 moderate to severe hot flashes weekly. Compared to placebo, subjects receiving Angeliq 0.25 mg drsp/0.5 mg E2, achieved statistically significant reduction in the frequency and severity of moderate to severe vasomotor symptoms at Week 4 and Week 12.