Unigene Laboratories, Inc. and its licensee Tarsa Therapeutics announced positive results from its Phase 3 study of Ostora in 565 postmenopausal women for the treatment of postmenopausal osteoporosis. The ORACAL study was a multinational, randomized, double-blind, double-dummy, placebo-controlled trial of Ostora compared to placebo and to commercially available, synthetic salmon calcitonin administered by nasal spray. The primary efficacy endpoint was the percentage change in lumbar spine bone mineral density after one year of treatment. The data demonstrated that Ostora achieved all of the efficacy endpoints in the trial and indicated that the safety profile of Ostora did not substantially differ from nasal calcitonin or placebo, and that Ostora also appeared to be significantly less immunogenic than nasal calcitonin spray.
Ostora is an oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.
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