Bazedoxifene is a third generation selective estrogen receptor modulator

Selective estrogen receptor modulator

Selective Estrogen Receptor Modulators are a class of compounds that act on the estrogen receptor. A characteristic that distinguishes these substances from pure receptor agonists and antagonists is that their action is different in various tissues, thereby granting the possibility to selectively...

 (SERM), under development by Pfizer

Pfizer

Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...

 following the completion of their takeover of Wyeth Pharmaceuticals

Wyeth

Wyeth, formerly one of the companies owned by American Home Products Corporation , was a pharmaceutical company. The company was based in Madison, New Jersey, USA...

. Pfizer are seeking approval for bazedoxifene in the prevention and treatment of postmenopausal

Menopause

Menopause is a term used to describe the permanent cessation of the primary functions of the human ovaries: the ripening and release of ova and the release of hormones that cause both the creation of the uterine lining and the subsequent shedding of the uterine lining...

 osteoporosis

Osteoporosis

Osteoporosis is a disease of bones that leads to an increased risk of fracture. In osteoporosis the bone mineral density is reduced, bone microarchitecture is deteriorating, and the amount and variety of proteins in bone is altered...

. Bazedoxfiene is the result of an exclusive research collaboration between Wyeth Pharamceuticals

Wyeth

Wyeth, formerly one of the companies owned by American Home Products Corporation , was a pharmaceutical company. The company was based in Madison, New Jersey, USA...

 and Ligand Pharmaceuticals.

It is approved in the European Union

European Union

The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

, and is currently in the late phases of review by the United States' Food and Drug Administration

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

. When approved, bazedoxifene is to be sold by Pfizer under the tradename Viviant in the US and Conbriza in the EU. Bazedoxifene's combination with conjugated estrogens, Aprela, is currently undergoing Phase III studies.

History of approval

Wyeth received an approvable letter for bazedoxifene in late April 2007. The FDA called for final safety and efficacy data from Phase III studies, and acceptable valuation of manufacturing and testing facilities where problems were found earlier in the year. Wyeth was working with the FDA to resolve these issues, and expected an FDA action date at the end of 2007.

As of July 2009, the FDA have not given approval for the use of bazedoxifene in the US.

The drug was approved in the European Union by the European Medicines Agency

European Medicines Agency

The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...

on April 27, 2009.

Synthesis