Data supporting robust tamper-resistant features of Oxycodone DETERx®
CUMBERLAND, R.I.--(BUSINESS WIRE)-- 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, multi-particulate formulation, demonstrating the effect of crushing techniques on particle size reduction (PSR) and the resulting drug release. Oxycodone DETERx® was evaluated and compared to a commercially available reference product. The poster entitled, “Comparison of the Crush Resistant Properties of Oxycodone DETERx, a Multiparticulate, Extended-Release, Tamper Resistant Formulation Versus a Currently Marketed Oxycodone Extended-Release Product,” was presented at the 6th Annual Pain Therapeutics Summit, held in San Jose, California from October 3-4, 2012.
Extended-release formulations of opioids are known to be attractive targets for non-medical use because they contain relatively large doses of drug. Crushing these dosage forms can defeat the intended extended-release properties and result in the immediate availability of the opioid which is known as “dose dumping.” Crushed formulations are commonly self-administered by abusers orally, intranasally or by IV injection, resulting in euphoria (“high”). Legitimate pain patients also may crush the formulation to facilitate swallowing, which significantly increases their risk of serious adverse events and potentially death. For this reason, all commercially available extended-release opioid products carry warnings related to product tampering. The warnings state that the product is designed to work properly only if swallowed intact and that taking cut, broken, chewed, crushed, or dissolved product can result in a potentially fatal overdose.
The poster summarizes key findings of an extensive evaluation of the Oxycodone DETERx® formulation after crushing with a number of commonly available household tools (e.g., coffee grinder, pill crusher, etc.). These findings are compared to the results of crushing a commercially available reference product using the same study protocol.
Due to the small size of the oxycodone DETERx® particles, visual observation alone was insufficient to determine the impact of crushing techniques. Microscopy and particle size measurement with laser diffraction revealed that 5 of the 10 methods produced no change in the particle size of Oxycodone DETERx®. The other 5 methods produced only minor changes in the particle size of Oxycodone DETERx®. The impact of these changes on the drug release rate were measured by dissolution studies which demonstrated that Oxycodone DETERx® retained its extended-release properties after PSR for all of the crushing methods tested, with no cases of dose dumping. The results for Oxycodone DETERx® were superior to the results demonstrated with the reference product.
“These findings confirm the superior crush-resistant properties of Oxycodone DETERx®,” said Michael Heffernan, CEO of Collegium. “It is becoming increasingly recognized that tamper-resistant, extended-release opioids play an important role in the fight against prescription pain medication abuse. Oxycodone DETERx® has been designated Fast Track Status by the FDA and we are currently enrolling in the Phase 3 study. The crushing studies presented in this poster represent only a subset of our extensive evaluation of potential tampering methods and the resulting information will be included in our NDA, which is targeted for filing by the end of 2013.”
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, insufflations, 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 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. Oxycodone DETERx® (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.
Collegium Pharmaceutical, Inc.
Michael Heffernan, President, 401-762-2000, x220
Source: Collegium Pharmaceutical, Inc.