FDA Approves Lower Dose Angeliq Tablets

Bayer HealthCare has received approval from the FDA for a lower dose formulation of Angeliq (drospirenone and estradiol) for treatment of moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The efficacy of the lower dose Angeliq tablets (0.25mg drospirenone/0.5mg estradiol) was evaluated in a randomized, double-blind, placebo-controlled trial for 12 weeks in 735 postmenopausal women. Compared to placebo, patients receiving low dose Angeliq tablets achieved a statistically significant reduction in the frequency and severity of moderate to severe vasomotor symptoms at Week 4 and Week 12. Patients experienced a decrease of approximately two episodes per day at Week 4 and a decrease of approximately three episodes per day at Week 12. The new formulation will be available by prescription shortly.   

Angeliq is already available in a 0.5mg drospirenone/1mg estradiol dosage strength 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.

For more information visit www.angeliq-us.com.