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

CUMBERLAND, RI-- (BUSINESS WIRE)—December 20, 2007— Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced detailed study results from its recently completed proof of concept clinical trial for its abuse deterrent, sustained release, oral oxycodone formulation (COL-003). COL-003 is currently in development for the management of moderate to severe pain. The Company had previously reported the top line results of this study. In addition, the Company today announced that the U.S. Federal Drug Administration (FDA) has granted Fast Track Designation for COL-003. Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and demonstrate the potential to address unmet medical needs. Fast track designation enables a sponsor to have more frequent and timely communication with the FDA regarding product development plans and may also result in eligibility for priority review of the New Drug Application.

Product Description

The recently completed open-label, controlled, single dose, cross-over comparison study (CP-OXYDET-01) assessed (1) the safety and pharmacokinetics of single dose administration of two formulations of COL-003 (formulations A and B) as compared to a marketed reference product (OxyContin®) and (2) the influence of a common method of tampering (i.e. chewing) on pharmacokinetics of one formulation of COL-003 (subjects opened the capsules and chewed the contents before administration). All of the treatments were administered to subjects 30 minutes after a meal.

Study Results:

The mean pharmacokinetic parameters for each treatment arm are shown in the table below.

Clinical Trial CP-OXYDET-01 Mean Pharmacokinetic Parameters
Formulation/Regimen	Cmax (ng/mL)	AUCINF (hr*ng/mL)
COL-003A/ Intact Dosage Form	18.7	215
COL-003A/ Chewed Dosage Forma	18.4	224
COL-003B/ Intact Dosage Form	21.4	239
Reference Product/ Intact Dosage Form	20.5	222
aCapsule contents chewed by subjects for 60 seconds and swallowed with aid of water

Both COL-003A and COL-003B produced a plasma exposure similar to the marketed reference product, OxyContin®, when administered to subjects in a fed state. Trial results indicated that formulation COL-003B was bioequivalent to the reference product (i.e. confidence intervals were within FDA 80-125% limits). In one arm of the study, subjects chewed the COL-003 formulation prior to swallowing as a controlled simulation of misuse. The plasma profile for the chewed dosage form was also bioequivalent to COL-003 when administered whole and as intended, suggesting that misuse by chewing would not result in a spike in plasma level as desired by the abuser.

The Company is in the process of submitting the final study report to the FDA as well as requesting a meeting to discuss the Proof of Concept trial data and its plans for the pivotal clinical program. The Company plans to commence the pivotal clinical program in the second half of 2008.

"The results of the proof of concept trial validate our DETERx delivery platform. Our pre-clinical models were highly predictive of the in vivo activity and this enables us to quickly modify the formulation to achieve the desired pharmacokinetics as well as screen additional molecules incorporated in the DETERx technology. We believe DETERx has broad utility for a variety of drug molecules with and without abuse potential. We intend to accelerate the COL-003 program and to work closely with the FDA to move the product expeditiously through the development process” said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical. “We are pleased that the FDA has recognized that COL-003 may address the public health need for an abuse deterrent sustained release opioid product for the treatment of moderate to severe pain as demonstrated by the granting of fast track designation”.

About Collegium Pharmaceutical

Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through formulation based product improvements protected by intellectual property (IP). Collegium focuses on product development in respiratory diseases, CNS disorders, and skin and skin related disorders through its subsidiary, Onset Therapeutics (www.onsettx.com). For more information, visit the Company’s website at www.collegiumpharma.com.


OxyContin® is a registered trademark of Purdue Pharma