The allowed patent is a formulation patent and covers the DETERx technology platform. As such, the claims cover multiple products in Collegium’s development pipeline. This is the sixth US patent related to the DETERx technology platform and is part of Collegium’s larger portfolio of US and international filings.
Oxycodone DETERx, Collegium’s lead development program, is the first of a number of product candidates utilizing the DETERx technology platform. Collegium recently announced the completion of patient enrollment in the pivotal Phase III study for Oxycodone DETERx.
Pending positive results of the Phase III study in the second quarter of 2014, Collegium expects to submit an NDA for Oxycodone DETERx in the second half of 2014. The product has been designated Fast Track Status by the FDA.
In addition to the Phase III study to establish the safety and efficacy of the product, Collegium has executed a comprehensive development program for evaluation of the product’s abuse-deterrent properties consistent with the FDA’s recently-issued Draft Guidance, ‘Abuse-Deterrent Opioids – Evaluation and Labeling’.
Collegium CEO Michael Heffernan noted these newly allowed claims continue to strengthen and expand the company’s overall patent coverage for the DETERx technology platform.
"We are continuing to focus on the prosecution of additional patents that support our lead product and the DETERx® technology in both the U.S. and internationally," Heffernan added.