The initiative follows a formal pre-NDA verification with the FDA that verified the results from Tarsa’s Phase III ORACAL trial and the requirements for regulatory approval.
The Phase III ORACAL trial has demonstrated the positive efficacy and safety results of oral calcitonin tablet in the treatment of postmenopausal osteoporosis.
Currently, Ostora is being evaluated in a one-year double-blind Phase II study in postmenopausal women who have low bone mass (osteopenia) and are at increased risk of fracture.
Under a licensing agreement with Unigene Laboratories, Tarsa is developing its Ostora oral calcitonin and attains exclusive development and worldwide commercialization rights to Unigene’s oral calcitonin product.
Tarsa CEO David Brand said the recent dialogue with the FDA was productive and they are on track to submit an NDA for Ostora as a treatment for postmenopausal osteoporosis in the second half of 2012.