Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that U.S. Patent No. 8,758,813 has been issued by the U.S. Patent and Trademark Office (USPTO). 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 U.S. patents that are Orange Book listable. All issued patents provide protection until 2025. Outside of the U.S., 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comprehensive development program for evaluation of the product's abuse-deterrent properties consistent with FDA's 2013 Draft Guidance, "Abuse-Deterrent Opioids - Evaluation and Labeling."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 U.S. and internationally," states Michael Heffernan, CEO of Collegium.
About DETERx® Technology
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 U.S. and international patents and patent applications. Oxycodone DETERx® is the first of a number of product candidates using the DETERx® platform.
About Collegium Pharmaceutical, Inc.
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. The DETERx® oral drug delivery technology provides extended release delivery, unique abuse-deterrent properties, and flexible dose administration options. For more information, visit the Company's website at www.collegiumpharma.com.
Vice President, Corporate Development
Collegium Pharmaceutical, Inc.
SOURCE: Collegium Pharmaceutical, Inc.