FDA approved next-generation risedronate
The FDA has approved a next-generation, delayed-release formulation of risedronate sodium for the treatment of postmenopausal osteoporosis.
According to manufacturer Warner Chilcott, the delayed-release risedronate (Atelvia) is non-inferior to that of standard risedronate (Actonel).
Based on data from a randomized, double blind trial of 900 women that the agency analyzed before approving the bisphosphonate, increases in bone mineral density were non-inferior with 1 year of once-weekly 35-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 Warner Chilcott statement.
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 to be available in early 2011.