This approval of the intravenous form of the drug will provide an alternative for patients who have difficulty with oral bisphosphonate dosing requirements, including an inability to sit upright for 30 to 60 minutes and/or swallow a pill. The tablet version of the drug was approved by the FDA in March 2005.
Additionally, because Boniva injection will be administered by healthcare professionals, clinicians will have a greater awareness of patient compliance with therapy.
Boniva injection was approved by the FDA based on results of a clinical trial in 1,358 women with postmenopausal osteoporosis.
“(Boniva) represents an important new opportunity to bring the bone-strengthening benefits of Boniva to more women – including those who have difficulty with dosing requirements of oral bisphosphonates,” said Dr Robert Recker, director of Creighton University Osteoporosis Research Center, Omaha.