FDA approves Wyeth's low-dose Prempro

A low-dose formulation of Wyeth Pharmaceuticals' Prempro (conjugated estrogens/medroxyprogesterone acetate) has received approval from the US Food and Drug Administration for the treatment of moderate to severe symptoms associated with menopause, including vaginal dryness, hot flashes and night sweats, and for the prevention of postmenopausal osteoporosis. The new formulation comprises 0.3mg conjugate estrogen and 1.5mg medroxyprogesterone acetate. Furthermore, the FDA has expanded the indication for Prempro 0.45mg/1.5mg to include the prevention of postmenopausal osteoporosis; this formulation received approval earlier this year (Marketletter March 24).

The company noted that data supporting the efficacy and tolerability of the two low-dose formulations were based on the HOPE study, a prospective, randomized, double-blind, placebo-controlled, multicenter trial of 2,673 healthy postmenopausal women (40-65 years of age). Wyeth said it expects to launch Prempro 0.45mg/1.5mg by early summer this year and Prempro 0.3mg/1.5mg by year-end.