Can Pfizer rescue hormonal replacement therapy with its Aprela?

In a market still plagued with safety concerns, US pharma behemoth Pfizer (NYSE: PFE) has an opportunity to restore market growth for hormonal replacement therapy (HRT) with its new combination product, Aprela (bazedoxifene/conjugated estrogens). To do this it must rebuild public and general practitioner confidence in the therapy area, says independent market analyst, Datamonitor.

The last Phase III clinical study announced by Wyeth, before its takeover by Pfizer, showed that Aprela - which has yet to receive regulatory approval in the USA - significantly reduced the severity and frequency of several menopausal symptoms, including vasomotor symptoms and increased bone mineral density (BMD) values at the lumbar spine and total hip. Bazedoxifene alone was cleared in Europe, under the trade name Conbriza, as a treatment of post-menopausal osteoporosis in women at increased risk of fracture (The Pharma Letter April 28, 2009) and Pfizer started rolling it out in Japan for this indication this year (TPL October 2010).