An osteoporosis product, comprising Procter & Gamble/Sanofi-Aventis’ Actonel (risedronate) and calcium, has been given a nod of approval from the US Food and Drug Administration, providing patients with the first ever treatment option combining a prescription osteoporosis drug with tablets of the crucial bone mineral calcium. In addition, this line extension could also prove beneficial to P&G/Sanofi-Aventis, which have just witnessed a tentative approval of a generic rival to Actonel from Teva Pharmaceuticals [[15/08/05e]].
The new four-week therapy comprises seven tablets per week, one of Actonel and six providing 500mg calcium, and follows a report from the Surgeon General calling for osteoporosis regimens to be simplified. Recent surveys have shown that many women do not take sufficient calcium or may take it incorrectly with a bisphosphonate drug, such as Actonel. For example, 73% of women who filled a bisphosphonate prescription purchased less than the equivalent of one calcium tablet per day (Source: Information Resources), and 26% of women take calcium within 30 minutes of their bisphosphonate, which lowers its efficacy (Source: Harris Interactive).
In the USA, some 8 million women are estimated to have osteoporosis, and a further 27 million to have low bone mass.