The US Patent and Trademark Office (USPTO) has issued US patent No. 8,758,813 to Collegium Pharmaceutical, Inc.. The patent relates to Collegium’s Oxycodone DETERx formulation and contains claims that cover the company’s lead product, an abuse-deterrent, extended-release oxycodone product utilizing its proprietary DETERx technology.
Collegium currently has six US patents that are Orange Book listable. All issued patents provide protection until 2025. Outside of the US, Collegium has three patents in Japan, Australia and Canada.
Oxycodone DETERx is currently in phase 3 clinical development and topline data is anticipated in Q3 2014. The product has been designated Fast Track Status by the FDA. In addition to the phase 3 study to establish the safety and efficacy of the product, Collegium has executed a comprehensive development programme for evaluation of the product’s abuse-deterrent properties consistent with FDA’s 2013 Draft Guidance, “Abuse-Deterrent Opioids - Evaluation and Labeling.”
“The newly issued patent strengthens and expands our patent coverage for Oxycodone DETERx, our lead development product. We are continuing to focus on the prosecution of additional patents that support our lead product and the DETERx technology in both the US and internationally,” states Michael Heffernan, CEO of Collegium.
The DETERx drug delivery platform consists of a multi-particulate matrix formulation in a capsule. While developed primarily to provide abuse-deterrent properties to protect against common methods of tampering such as chewing, crushing, insufflation and extraction for IV injection, the multi-particulate design is expected to enable patients with difficulty swallowing to open the capsule and administer the contents on food or via a gastrostomy tube, while maintaining the extended-release properties of the product. DETERx technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have narrow therapeutic windows that would benefit from protection against misuse such as breaking, crushing, grinding or dissolving the product. The formulation platform is covered by US and international patents and patent applications. Oxycodone DETERx is the first of a number of product candidates using the DETERx platform.
Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx formulation platform for the treatment of chronic pain.