Wednesday, November 17, 2010
New Osteoporosis Drug
FDA approves new delayed release osteoporosis drug.
The AP (10/12) reports, "Irish drug developer Warner Chilcott PLC said Monday the US Food and Drug Administration has approved its new drug for treating postmenopausal osteoporosis." Warner Chilcott said "Atelvia [risedronate] is the next generation of its popular osteoporosis drug Actonel, which it acquired when it bought Procter & Gamble Co.'s global branded prescription drug business for $3.1 billion last year." Roger Boissonneault, Warner Chilcott's president and chief executive, said, "We believe the dosing convenience of Atelvia sets it apart from other treatment options for osteoporosis patients."
According to MedPage Today (10/12, Gever), the new "formulation...may be easier for some patients." Atelvia "can be taken with food, whereas patients are instructed to take ordinary risedronate (Actonel) on an empty stomach." Notably, the "delayed-release drug was approved only for treating osteoporosis in postmenopausal women, not for other indications for which Actonel is approved including glucocorticoid osteoporosis, Paget's disease, or osteoporosis in men."
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