Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that a patent has been issued by the US Patent and Trademark Office (USPTO) covering its Oxycodone DETERx formulation.
Additionally, an application has been allowed for issuance as a new patent by the USPTO.
Both patents relate to Collegium's Oxycodone DETERx formulation and contain claims that cover the company's product, an abuse-deterrent, extended-release oxycodone product utilizing its proprietary DETERx technology.
These are the fourth and fifth US patents related to the DETERx drug delivery technology.
Oxycodone DETERx is nearing completion of enrollment in its Phase III clinical program with a planned NDA filing in the first half of 2014.
The product has been designated fast track status by the US Food and Drug Administration (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 Guidance, 'Abuse-Deterrent Opioids - Evaluation and Labeling'.
Collegium CEO Michael Heffernan noted these newly issued claims covering the company's platform technology continue to strengthen and expand its overall patent coverage for Oxycodone DETERx.
"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.
