Collegium Pharmaceutical Inc. Presents Clinical Data for DETERx(TM) Abuse-Deterrent Sustained Release Technology at American Pain Society Meeting

2008-05-08 18:12:11 -

www.collegiumpharma.com - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced the presentation of a scientific poster summarizing the results of a pharmacokinetic study for its abuse-deterrent, sustained release oral oxycodone formulation (COL-003). The poster, entitled, "Abuse-Deterrent Properties and Pharmacokinetics of a Novel Sustained Release Formulation of Oxycodone for the Treatment of Moderate to Severe Pain", will be presented at the 27th Annual Scientific Meeting of the American Pain Society (APS), May 8-10, in Tampa, Florida. The poster will be displayed and presented on May 8th.

COL-003 contains oxycodone as its active ingredient and utilizes the Company's DETERx(TM) technology. COL-003 is a sustained release oral dosage form designed to be more resistant to tampering than traditional formulations of the drug. COL-003 has undergone extensive in vitro dissolution and tamper resistance testing as well as pharmacokinetic studies in healthy volunteers. In order to assess the tamper resistant qualities of the COL 003, one arm of the study included subjects that opened the capsule and chewed the contents prior to swallowing. Crushing or chewing the formulation prior to ingestion is a commonly used method of abusing the currently marketed product OxyContin(R). The study demonstrated that the plasma profile for COL 003 when chewed was bioequivalent to COL-003 when administered whole and as intended, suggesting that attempting to breakdown the sustained release mechanism by chewing would not result in a meaningful increase in plasma level as desired by the abuser. Based on the in vitro and in vivo studies, COL-003 is expected to provide adequate plasma concentrations to effectively treat pain while decreasing the effectiveness of tampering methods used to prepare conventional tablets for abuse via oral administration (e.g. chewing, crushing), intravenous injection and nasal administration (i.e. snorting).

As previously reported, COL-003 is currently under clinical development pursuant to an active investigational new drug application on file with the United States Food and Drug Administration ("FDA"). Collegium recently reported receipt of Fast Track Designation for the product from the FDA.

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.

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