The Phase III multinational, randomized, double-blind, double-dummy, placebo-controlled trial enrolled 565 postmenopausal women with established osteoporosis in six countries.
The study’s primary endpoint was the percent change in lumbar spine bone mineral density (BMD) after one year of treatment.
Based on the study design and specific endpoints that were agreed with the US Food and Drug Administration (FDA) in a Special Protocol Assessment (SPA) agreement, Tarsa Therapeutics intends to use the results to support a new drug application (NDA) submission by the end of this year.
By early 2012, Tarsa also plans to submit a marketing authorization application (MAA) to the European Medicines Agency (EMA).
Tarsa is developing its oral calcitonin program under a licensing agreement with Unigene Laboratories.
Unigene provides Tarsa with exclusive development and worldwide commercialization rights to its oral calcitonin product, with the exception of China.