FDA approves new osteoporosis medication
This week, the Food and Drug Administration approved a delayed-release formulation of risedronate sodium for the treatment of postmenopausal osteoporosis. According to manufacturer Warner Chilcott, Atelvia is equivalent to standard risedronate (Actonel), Endocrine Today
Based on data from a randomized trial of 900 women - that the agency analyzed before approving the bisphosphonate - increases in bone mineral density were the same with 1 year of once-weekly 35-milligram (mg) delayed-release risedronate as compared with daily 5-mg immediate-release risedronate.
"We believe the dosing convenience of Atelvia sets it apart from other treatments for osteoporosis patients," company officials said in a press release.
Delayed-release risedronate is recommended to be taken after a full breakfast and with at least four ounces of water. When taken before breakfast on an empty stomach, the drug often resulted in severe abdominal pain.
The company expects the bisphosphonate will be available in early 2011.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 44 million Americans are at increased risk for bone fracture.