Healthcare Industry News:  oxycodone 

Biopharmaceuticals Drug Delivery FDA

 News Release - June 15, 2007

Collegium Pharmaceutical Inc., Announces the Filing of IND for Abuse Deterrent Sustained Release Opioid Product

CUMBERLAND, R.I.--(HSMN NewsFeed)--Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that it has filed an Investigational New Drug ("IND") for its patent pending abuse deterrent sustained release opioid formulation COL-003. This follows a pre-IND meeting that the Company held with the FDA in March 2007 at which time the Company received guidance on the basis of approval requirements for the product. Collegium intends to commence its clinical development program immediately upon the acceptance of the IND by the FDA. Based upon feedback from the FDA, the product will likely qualify for fast track review status due to the potential public health benefit of the product regarding intentional and unintentional overdose.

Collegium's proprietary oral delivery technology DETERx(TM) is the basis of the abuse deterrent and sustained release characteristics of the product. For the currently marketed formulation of sustained release oxycodone simple methods such as chewing, crushing and/or dissolution in water can expose the entire dose of oxycodone contained in the formulation. Tampering with the dosage form and self administering it orally, nasally or intravenously results in a rapid rise in oxycodone blood concentration rather than the gradual rise in plasma concentration achieved when the tablet is taken as directed. Since a rapid rate of rise in blood concentration is more likely to result in drug liking and reinforcement than a slower rise in plasma exposure(1), this practice increases the abuse liability of the drug. For oxycodone and other opioids, a rapid rise in plasma concentration can also cause respiratory depression and is potentially lethal, depending on the dose. The health risk associated with oxycodone abuse is exemplified by Drug Abuse Warning Network (DAWN) data, which estimated 22,397 emergency department mentions for oxycodone in 2002.

DETERx is a sustained release oral dosage form designed to be more resistant to tampering and abuse than traditional formulations of the drug. This product has undergone extensive in vitro testing and pre-clinical development and has met its pre-clinical endpoints for dissolution and in vitro abuse simulation testing. Based on these studies the product is expected to be beneficial in deterring abuse by oral administration (e.g. chewing, crushing), intravenous injection and nasal administration (i.e. snorting). Using its flexible DETERx delivery technology, the company is in the process of completing pre-clinical testing on additional opioid candidates, as well as a compound for the treatment of ADHD. Pending the data from the initial proof of concept trial on COL-003, Collegium will develop its future plans for additional candidates using the DETERx system.

"We are very pleased to have advanced the DETERx technology from a concept in the lab into a product ready for the clinic. We have a clear understanding of the regulatory requirements necessary for its approval" said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical. "This product has the potential to address a large unmet public health issue associated with the use the opioids in the treatment of chronic pain"

About Collegium Pharmaceutical

Collegium Pharmaceutical, Inc. is a privately held specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through product improvement and line extension strategies protected by intellectual property (IP). Collegium applies customized pharmaceutical formulations and IP strategies to active ingredients that have been shown to be safe and effective, creating a portfolio of improved pharmaceutical products with potentially less development risk and shorter times to market. For more information, visit the Company's website at www.collegiumpharma.com

(1) Mansbach, RS, Moore, RA, 2006. Formulation considerations for the development of medications with abuse potential. Drug and Alcohol Dependence 83S, S15-S22.


Source: Collegium Pharmaceutical

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