Collegium Pharmaceutical Inc. Announces Successful Completion of Proof of Concept Study for its Abuse Deterrent Sustained Release Opioid Product

CUMBERLAND, R.I.--(BUSINESS WIRE)--Oct 31, 2007 - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced a top line summary from its recently completed proof of concept clinical trial for its patent pending, abuse deterrent, sustained release, oral oxycodone formulation COL-003. COL-003 utilizes Collegium's DETERx(TM) technology and 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 has met its development endpoints for dissolution and in vitro abuse simulation testing. Based on these studies the product is expected to be effective in deterring abuse by oral administration (e.g. chewing, crushing), intravenous injection and nasal administration (i.e. snorting). The proof of concept study was designed to assess the pharmacokinetics of COL-003 under various conditions in healthy subjects.

The proof of concept study was a single dose, open-label, controlled, cross-over comparison study in 12 healthy subjects designed to evaluate the safety and pharmacokinetics of two formulations of COL-003. Both formulations were evaluated following oral administration of an intact 20 mg capsule and one of the formulations was evaluated following consumption by chewing (a common form of oral abuse). In addition, a currently marketed, sustained-release formulation, Oxycontin(R), an active control, was swallowed intact. All of the above treatments were swallowed 30 minutes after a morning meal. In a separate arm of the study, subjects swallowed a 20 mg dose of COL-003 in the fasted state. A washout period of at least one week occurred between each of the 5 arms of the crossover study.

The top line results of the study demonstrated the following:

-- COL-003 exhibited controlled release pharmacokinetic characteristics with plasma concentrations measurable throughout a 24 hour period.

-- COL-003 was bioequivalent to Oxycontin(R) under fed conditions.

-- COL-003 bioavailability as measured by Cmax, and AUC was similar when dosed intact or after opening the capsule, emptying the contents in the mouth and chewing prior to swallowing.

-- COL-003 bioavailability was decreased when dosed to fasting subjects (relative to fed subjects).

The Company intends to release detailed study results shortly. "We are very pleased with the results of the proof of concept trial. The bioavailability of COL-003 under various conditions was as predicted in our in vitro models" said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical. "We believe that this proof of concept data validates the DETERx(TM) platform as a technology that can prevent lethal overdoses if the dosage form is broken, crushed or chewed, common methods of misuse. Based upon this data, we intend to accelerate our development of COL-003, as well as the additional targets that we have in development using the DETERx(TM) technology".

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

Oxycontin(R) is a registered trademark of Purdue Pharma

Contact

Collegium Pharmaceutical, Inc.
Steven N. Tannenbaum, 401-762-2000 Ext. 16
stannenbaum@collegiumpharma.com

Posted: October 2007

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