CANTON, MA – March 19, 2014 -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that U.S. Patent Application No. 12/965,572 has been allowed for issuance as a new patent by the U.S. Patent and Trademark Office (USPTO). 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 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 the completion of patient enrollment in the pivotal Phase 3 study for Oxycodone DETERx®. Pending positive results of the Phase 3 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 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program for evaluation of the product's abuse-deterrent properties consistent with the FDA's recently-issued Draft Guidance, "Abuse-Deterrent Opioids - Evaluation and Labeling."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® technology 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 and abuse 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, directly in the mouth, or via enteral 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® technology 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.