Collegium Pharmaceutical Inc. Announces Submission of a Request for Special Protocol Assessment to FDA for Pivotal Trial for Tamper Resistant, Extended Release Opioid (COL-003).

* COL-003 is a Tamper Resistant, Abuse Deterrent, Extended Release Product containing Oxycodone 

CUMBERLAND, R.I. -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that it has submitted a proposal to the US Food and Drug Administration (FDA) for a Phase III pivotal trial of COL-003 under the Special Protocol Assessment (SPA) process. The SPA process allows for official FDA evaluation of the clinical protocol of a Phase III clinical trial intended to form the primary basis for an efficacy claim and provides trial sponsors with a binding written agreement that the design and analysis of the trial are adequate to support the submission of a marketing application if the trial is performed in accordance with the SPA.

About COL-003

COL-003 is a tamper resistant formulation of extended release oxycodone that incorporates the Company's patented DETERx[TM] delivery technology. The product is currently under clinical development pursuant to an active Investigational New Drug Application and has received Fast Track Designation from the FDA. COL-003 is being developed for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

COL-003 has been the subject of a number of clinical studies designed to assess its pharmacokinetic and tamper resistant properties. The pharmacokinetic results are consistent with a 12 hour dosing schedule. Results from two independent studies, during which opening the capsule and chewing the contents was assessed, indicate that this common method of tampering (chewing) caused minimal change in the plasma concentration of oxycodone and was bioequivalent to administering the capsule intact. In addition, COL-003 has been extensively tested in vitro in a series of solvent extraction studies and other tamper simulations to assess its resistance to other common means of misuse including crushing, snorting, and injection. The Company expects to commence its single Phase III pivotal efficacy trial in the second half of 2009.

About DETERx[TM]

DETERx[TM] is a proprietary tamper resistant, extended release delivery platform that can be applied to drugs prone to abuse as well as drugs that have a narrow therapeutic window in which the inadvertent destruction of the time release system (crushing, breaking, chewing) can cause harm to a patient. The Company's DETERx[TM] platform consists of a multi-particulate matrix formulation in a capsule and is covered by a patent that expires in 2025. While developed primarily to provide tamper resistant, extended release properties, the multi-particulate design has the potential to allow patients with difficulty swallowing to open the capsule and administer the contents on food or with water, while maintaining the extended release properties of the product. In addition to COL-003, the Company has a number of additional DETERx [TM] product candidates in development for the treatment of pain and ADHD.

"Opioid abuse remains a major public health issue and tampering with extended release opioids exacerbates this problem. Both intentional tampering and accidental misuse of currently available opioid formulations is prevalent and problematic. Based upon our clinical and non-clinical studies to date, COL-003 appears to provide a solution to this problem by delivering therapeutic amounts of active drug over a 12 hour period and by offering resistance to common forms of tampering including chewing, crushing, and solvent extraction that precede misuse by oral ingestion, snorting or injection" said Michael Heffernan, President and CEO, Collegium Pharmaceutical.

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 is focused on building a portfolio of pain products that incorporate its patent protected DETERx[TM] formulation platform that provides for extended release and tamper resistance. The Company, through its subsidiary, Onset Therapeutics (www.onsettx.com), develops and commercializes products for skin and skin related disorders using its novel DELEVO[TM] Foam Technology. For more information, visit the Company's website at www.collegiumpharma.com.