SCOLR Pharma, Inc. has initiated pilot bioavailability testing in Canada of its Controlled Delivery Technology (CDT) raloxifene tablets. 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 Therapeutic Products Directorate, Health Canada, for its Clinical Trial Application to commence a 20 subject, randomized five-way crossover, open-label, 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.
Stephen J. Turner, SCOLR Pharma's vice president and chief technology officer, said, "The initiation of this study is the first human clinical application of our patented amino acid technology intended to address insoluble and poorly soluble compounds. In addition to CDT-based raloxifene hydrochloride, we also previously announced that we are initiating development of a CDT-based ondansetron hydrochloride formulation." Ondansetron hydrochloride is the active ingredient in Zofran, GlaxoSmithKline's widely used product to prevent chemotherapy and radiation-induced nausea and vomiting.
In 2004, Eli Lilly reported over $1 billion in global Evista sales.
Raloxifene hydrochloride is the active ingredient in Evista, Eli Lilly's immediate release raloxifene product for osteoporosis utilizing a different solubilization technology. In 2004, GlaxoSmithKline reported over $1.4 billion in global Zofran sales.