Collegium Announces Poster Presentation for Oxycodone DETERx, a Tamper-Resistant, Extended-Release Opioid at American Academy of Pain Management's 23rd Annual Clinical Meeting

CUMBERLAND, R.I.--(BUSINESS WIRE)--Sep 27, 2012 - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain, today announced the presentation of a scientific poster summarizing the results for Oxycodone DETERx®, its tamper-resistant, extended-release multiparticulate formulation showing that this product may be effectively administered via sprinkling on soft foods or through enteric feeding tubes. In vivo pharmacokinetic results showing its tamper-resistant properties when chewed were also summarized. The poster, titled “Alternative Methods of Oxycodone DETERx Administration,” was presented at the American Academy of Pain Management's 23rd Annual Clinical Meeting, held in Phoenix, Arizona from September 20th-23rd, 2012.

The scientific poster summarized key findings demonstrating the equivalence of the in vitro release profiles between the oxycodone DETERx® formulation administered as an intact capsule and alternate routes of administration, including opening the capsule and sprinkling the beads on soft foods, or through enteric feeding tubes such as nasogastric or gastronomy tubes. In vivo pharmacokinetic study results showing bioequivalence and safety between chewing of the oxycodone DETERx® beads compared with taking the capsule intact were also presented, demonstrating the tamper-resistant properties of oxycodone DETERx®.

Collegium believes that these alternate methods of administration with oxycodone DETERx® will benefit treatment of chronic pain in patients with difficulty swallowing. Treatment of chronic pain in many adults and children is complicated by problems associated with ingestion of solid oral dosage forms, especially extended-release formulations, due to dysphagia/odynophagia. These patient populations remain an unmet medical need.

“These findings confirm that the oxycodone DETERx® formulation may provide a patient benefit not available with other oral extended-release opioids, especially those that have tamper-resistant technologies, which make the tablets harder to crush,” said Michael Heffernan, CEO of Collegium. “There are a large number of chronic pain patients, including children, geriatrics and patients with concomitant illnesses, who cannot take solid oral dosage forms or who suffer from dysphagia, that may benefit from an extended-release, tamper-resistant oral opioid that can be administered as a sprinkle or through a gastric tube.”

About DETERx® Technology

The DETERx® drug delivery platform consists of a multi-particulate matrix formulation in a capsule. While developed primarily to provide tamper-resistant properties to protect against common methods of tampering such as chewing, crushing, insufflation and extraction for IV injection, the multiparticulate design is expected to enable patients with difficulty swallowing to open the capsule and administer the contents on food or via a gastronomy 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. COL-003 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 tamper-resistant properties, and flexible dose administration options. For more information, visit the Company's website at www.collegiumpharma.com.

Contact: Collegium Pharmaceutical, Inc.
Michael Heffernan, 401-762-2000, x220
President
mheffernan@collegiumpharma.com

 

Posted: September 2012

View comments

Hide
(web5)