Bazedoxifene

Bazedoxifene is a third generation selective estrogen receptor modulator (SERM), under development by Pfizer following the completion of their takeover of Wyeth Pharmaceuticals. Pfizer are seeking approval for bazedoxifene in the prevention and treatment of postmenopausal osteoporosis^[1]. Bazedoxfiene is the result of an exclusive research collaboration between Wyeth Pharamceuticals and Ligand Pharmaceuticals.

It is approved in the European Union (marketed in Italy and Spain), and is currently in the late phases of review by the United States' Food and Drug Administration. 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 for the treatment of postmenopausal symptoms (including the prevention of postmenopausal osteoporosis/treatment of osteopenia).

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 December 2011, the FDA have not given approval for the use of bazedoxifene in the US.^[2]

The drug was approved in the European Union by the European Medicines Agency on April 27, 2009.^[3]

Synthesis

Miller, C.P.; Harris, H.A.; Komm, B.S. (2002). "Bazedoxifene Acetate". Drugs of the Future 27 (2): 117. doi:10.1358/dof.2002.027.02.637843. 

References

1. ^ Biskobing, D. M. (2007). "Update on bazedoxifene: A novel selective estrogen receptor modulator". Clinical interventions in aging 2 (3): 299–303. PMC 2685267. PMID 18044180. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2685267.  edit
2. ^ "Drugs@FDA - Drug Names Beginning with "B"". Food and Drug Administration. 7 July 2009. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchResults_Browse&DrugInitial=B. Retrieved 2009-07-08. 
3. ^ "EPARs for authorised medicinal products for human use - Conbriza" (in various). European Medicines Agency. 26 May 2009. http://www.emea.europa.eu/humandocs/Humans/EPAR/conbriza/conbriza.htm. Retrieved 2009-07-08.