SCOLR Reports Positive Initial Clinical Results for CDT-Pseudoephedrine
SCOLR Pharma has achieved positive initial clinical results from the testing of its OTC 12-hour CDT pseudoephedrine tablets utilizing the company's patented controlled-delivery technology (CDT).
This is the first of three planned subject dosing studies that SCOLR Pharma is conducting in support of an abbreviated new drug application to the FDA later this year for a CDT-based 12-hour extended-release pseudoephedrine formulation.
Vice President and Chief Technology Officer Stephen Turner said, "This successful initial CDT Pseudoephedrine human study included 24 participants. They were split into two cross-over groups in fed versus fasted conditions. We compared the plasma levels of the 12-hour CDT-based pseudoephedrine tablets with levels obtained from currently marketed 12-hour extended release tablets. We found that the CDT formulation provided plasma levels that were well within the acceptable range of the levels for the currently marketed products.
"This study provides the basis for a larger scale study needed for U.S. regulatory approval. Due to the positive results from this first group of subjects, we do not plan to make any changes to the CDT-based tablets or the trial design before commencing the next two study segments," he said.