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news.Collegium Pharmaceutical has unveiled positive topline results from a clinical study evaluating Hydrocodone DETERx as a second product candidate using its proprietary DETERx drug delivery technology platform.
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The objective of this pharmacokinetic proof of concept study was to assess two prospective formulations of Hydrocodone DETERx in a bioavailability clinical study.
The primary goals were to assess the extended-release profile and the resistance to a common method of physical manipulation used by drug abusers – crushing. The drug release profile of the two formulations was characterized when taken intact after oral administration compared with opening the capsule and crushing the capsule contents (microspheres) prior to oral administration.
The results of the study demonstrated that both Hydrocodone DETERx product candidates were bioequivalent when comparing crushed and intact dosing, demonstrating resistance to physical manipulation.
One of the product candidates achieved the targeted pharmacokinetic profile for 12-hour dosing interval.
"There is a significant market opportunity and unmet need for a differentiated, abuse-deterrent formulation of extended-release hydrocodone. Based upon the results of this study and our in vitro characterization, we expect Hydrocodone DETERx to provide similar advantages and unique product characteristics as Xtampza™ ER, our first FDA approved product to utilize the DETERx technology platform," said Michael Heffernan, CEO of Collegium.
Based on the positive results of this study, Collegium plans to accelerate development of the lead Hydrocodone DETERx formulation candidate.