The company has been granted approval from Canada's Therapeutic Products Directorate to start the clinical trial, which will compare comparing three formulations of raloxifene based on SCOLR's Controlled Delivery Technology (CDT) to two control treatments.
Raloxifene was originated by Eli Lilly which sells its as Evista. This immediate-release product, which uses a different formulation technology, racked up over $1 billion (€796m) in global sales last year.
Stephen Turner, SCOLR Pharma's 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."
Last year, SCOLR Pharma reported positive results from animal studies using its CDT, revealing a significant increase in the total bioavailability and absorption rates with both raloxifene and nausea treatment ondansetron, a $1.4bn product sold as Zofran by GlaxoSmithKline. SCOLR is aiming at filing for raloxifene at the end of 2005.
SCOLR's amino acid platform is based on a matrix containing a granulated active ingredient, ionic resins or gums, and amino acids. Upon hydration the hydrophobic drug reacts with the amino acids to form weak complexes that are more soluble and can leach out of the matrix.
The company said the testing is intended to support a larger scale study planned for later this year as part of the US regulatory approval process.
"It is estimated that up to 40% of new chemical entities are poorly soluble. We believe that the application of our amino acid technology to raloxifene further demonstrates SCOLR Pharma's unique ability to work with difficult drugs," said Turner.