This second study, designed to meet the FDA requirements for US registration, will examine patients between 51 and 80 years old suffering from painful symptoms of knee osteoarthritis. The study will be conducted in multiple sites, including the US, with an estimated completion during the second half of 2011.
Michael Novinski, president and CEO of Emisphere, said: “This second phase III study is a significant step in facilitating the commercialization of oral salmon calcitonin in combination with our Eligen drug delivery technology in the US and worldwide. This combination may provide a solution to the growing problem of osteoarthritis.”