P&G To File NDA For Actonel In 1998

Procter & Gamble plans to file a New Drug Application with the US Foodand Drug Administration for its new-generation bisphosphonate Actonel (risedronate), for the treatment and prevention of osteoporosis, in the first half of next year. In March, the company filed for approval to market the drug for the treatment of Paget's disease.

An 18-month Phase III clinical study, presented at the ASBMR meeting, found that the drug, which works by inhibiting the bone resorption process, significantly increased bone density in women with osteoporosis. The three-arm trial enrolled 648 postmenopausal women with low lumbar bone mineral density but who were not on estrogen-replacement therapy.

One third of patients received risedronate 2.5mg, while another third were administered risedronate 5mg, the remainder being given placebo, according to Reuters. All patients were given calcium supplements every day.