Once-monthly Boniva
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Initial results of Roche/GlaxoSmithKline's Phase III study of once-monthly Boniva (ibandronate) for the treatment of postmenopausal osteoporosis show monthly dosing at 100 mg and 150 mg was "at least equivalent to the 2.5 mg daily regimen in increasing lumbar spine bone mineral density" after one year of treatment. The MOBILE (Monthly Oral Ibandronate in Ladies) study is continuing for a second year. Once-daily Boniva was approved in May 2003; the firms have delayed launch until a less frequent dosing regimen is approved (1Pharmaceutical Approvals Monthly June 1, 2003, In Brief). Merck's Fosamax (alendronate) and Procter & Gamble's Actonel (risedronate) are both dosed once weekly. Roche has projected Boniva will reach the market in 2005...