Ostora oral salmon calcitonin: Additional Phase III data

Additional data from the double-blind, double-dummy, international Phase III ORACAL trial in 565 postmenopausal women showed that once-daily oral Ostora significantly reduced levels of fasting C-terminal telopeptide of type I collagen (CTX-I), a biomarker of bone resorption activity, by 29.9% from baseline to 1 year vs. 11.4% for Miacalcin salmon calcitonin nasal spray (p<0.001). Tarsa, which has an SPA from FDA for the trial, plans to submit an NDA to FDA for Ostora before year end. Data were presented at the American Society for Bone and Mineral Research meeting in San Diego. ...