This testing is intended to support a larger scale study planned for later this year as part of the US regulatory approval process.
Scolr Pharma received authorization from the Health Canada’s therapeutic products directorate for its clinical trial application to commence a 20-subject fasting trial comparing three formulations of its CDT-based raloxifene to two controls.
Scolr Pharma previously reported a successful animal evaluation of a CDT-raloxifene formulation utilizing its patented amino acid technology. That evaluation showed a significant increase in the total bioavailability with its novel CDT formulation for raloxifene as compared with the controls in the study.
In 2004, Eli Lilly reported over $1 billion in global Evista sales, Eli Lilly’s immediate release raloxifene product for osteoporosis utilizing a different solubilization technology.