Healthcare Industry News:  Collegium Pharmaceutical 

Biopharmaceuticals Pain Management FDA

 News Release - July 12, 2007

Collegium Pharmaceutical Inc. Announces FDA Acceptance of IND for its Abuse Deterrent Sustained Release Opioid Product

CUMBERLAND, R.I.--(HSMN NewsFeed)--Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that the Investigational New Drug Application ("IND") for its patent pending, abuse deterrent, sustained release, oral opioid formulation COL-003 is now active following its acceptance by the U.S. Food and Drug Administration (FDA). The Company submitted the IND in June 2007.

A proof of concept clinical trial will be initiated immediately. The clinical trial is designed to assess the safety and pharmacokinetics of various formulations of COL-003 compared to a currently marketed product used as a control and with COL-003 consumed after chewing, a common route of misuse of sustained release opioids. The study is designed as an open label, controlled, crossover comparison study in healthy subjects.

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 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).

"The FDA acceptance of the IND initiates the clinical development of COL-003, a product and technology that was developed internally at Collegium" said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical. "Pending positive data from the proof of concept trial on COL-003, Collegium will implement its clinical development plan for the product as well as file IND's for two additional product candidates that utilize the Company's 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


Source: Collegium Pharmaceutical

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