Collegium Pharmaceutical Announces Issuance of U.S. Patent Covering DETERx®, an Abuse-Deterrent, Extended-Release, Technology Platform
Canton, MA – September 23, 2014 – Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that U.S. Patent No. 8,840,928 has been issued by the U.S. Patent and Trademark Office (USPTO). The issued patent covers the DETERx® technology platform. As such, the claims provide broad coverage for all opioids and other drugs prone to abuse that could leverage the DETERx® technology platform. This is the sixth issued U.S. patent related to the DETERx® technology platform and is part of Collegium’s larger portfolio of U.S. 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 positive Phase 3 study results for Oxycodone DETERx® and expects to submit an NDA in the fourth quarter of 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comprehensive development program for evaluation of the product’s abuse-deterrent properties consistent with the FDA’s Draft Guidance, “Abuse-Deterrent Opioids - Evaluation and Labeling.”
“These newly allowed claims continue to strengthen and expand our 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,” states Michael Heffernan, CEO of Collegium.
About DETERx® Technology
The DETERx® drug delivery platform consists of a microsphere-in-capsule formulation. 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 microsphere design is expected to enable patients with difficulty swallowing to open the capsule and administer the contents onto food or via a gastrostomy tube, while maintaining the extended-release properties of the product. The DETERx® technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have a narrow therapeutic index 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.