www.fdanews.com/articles/69342-scolr-starts-extended-release-cdt-pseudoephedrine-human-trials
SCOLR Starts Extended-Release CDT-Pseudoephedrine Human Trials
March 2, 2005
SCOLR Pharma has initiated human testing of its 12-hour controlled delivery technology (CDT)-based pseudoephedrine tablets.
The first of three planned U.S. studies was started on Feb. 26, 2005. These studies are intended to support an anticipated abbreviated new drug application submission to the FDA this summer.
SCOLR Pharma had previously announced an agreement with UPM Pharmaceuticals for the manufacture of the pseudoephedrine tablets to be used in these human trails. This is the company's second CDT-based formulation designed for the U.S. OTC market, the first being ibuprofen.