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news.SCOLR Pharma has achieved positive initial clinical results from the testing of its over-the-counter 12-hour pseudoephedrine decongestant tablets.
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This is the first of three planned subject dosing studies that SCOLR Pharma is conducting, in support of an abbreviated new drug application (ANDA) to the FDA later this year, for a controlled delivery technology (CDT)-based 12-hour extended release pseudoephedrine formulation.
The 12-hour tablets are about a third smaller than currently approved similar over-the-counter (OTC) products, but are designed to deliver an equivalent dose of pseudoephedrine.
“This study provides the basis for a larger scale study needed for US regulatory approval,” said Stephen Turner, vice president and chief technology officer at SCOLR Pharma. “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.”
The CDT-based pseudoephedrine tablets used in the initial study were cGMP manufactured by UPM Pharmaceuticals, which is also responsible for manufacturing the remaining clinical materials to support the ANDA filing later this year.
Branded products containing pseudoephedrine include Schering-Plough’s Afrin and Pfizer’s Pediacare and Sudafed.