Collegium Pharmaceutical Inc. Presents Scientific Poster for DETERx™ Tamper-Resistant, Extended Release Technology at American Academy of Pain Medicine’s 26th Annual Meeting

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced the presentation of a scientific poster summarizing the results of in vitro and pharmacokinetic studies for its tamper-resistant, extended-release oral oxycodone formulation (COL-003), which is the lead product candidate utilizing the Company’s DETERx™ technology. The poster, entitled, “Tamper-Resistant Properties and Bioavailability of a Novel, Multiparticulate, Extended-Release Formulation of Oxycodone for the Treatment of Moderate to Severe Pain”, will be presented at the American Academy of Pain Medicine’s 26^th Annual Meeting, February 3-6, in San Antonio, Texas. The poster will be displayed and presented on February 3^rd and 4^th.

The scientific poster being presented will summarize key findings pertaining to the in vitro and in vivo resistance of COL-003 to common methods of tampering such as crushing and chewing. Resistance to crushing and chewing is an important aspect of tamper-resistant formulations as these methods, when applied to conventional extended-release dosage forms, typically compromise the time release mechanism resulting in “dose dumping” when ingested or extracted in common solvents. The susceptibility of conventional marketed formulations to such physical manipulations has been a contributing factor to the continued popularity of these formulations among opioid abusers.

Key findings to be presented in the poster include:

• COL-003 was more resistant to particle size reduction than the marketed reference formulation when subjected to crushing with commonly available household tools;
• Crushed COL-003 microparticles and crushed reference product tablets were subjected to extraction in several ingestible solvents. COL-003 drug particles were resistant to dose dumping over a period of time where the marketed reference product exhibited release of the entire dose;
• In a pharmacokinetic study, healthy subjects chewed the contents of COL-003 capsules prior to administration as a controlled, clinical simulation of tampering. The plasma profile for COL-003 after chewing the capsule contents was bioequivalent to COL-003 when administered intact and as intended, suggesting that attempting to breakdown the time release mechanism by chewing would not result in a meaningful increase in plasma level as desired by the abuser; and
• The COL-003 formulation was orally bioavailable and exhibited extended-release pharmacokinetics consistent with 12-hour dosing.

Based on the in vitro and in vivo studies, COL-003 was less susceptible than the marketed reference product to two common methods of physical manipulation (i.e. crushing and chewing) frequently used by abusers to disrupt the time-release characteristics of conventional dosage forms. Furthermore, based on the in vivo results, it is expected that COL-003 will provide adequate plasma concentrations to effectively treat chronic pain.

“Opioid drug abuse and misuse continues to be a growing concern in the United States and there is a significant need to address this public health issue,” states Michael Heffernan R.Ph, President of Collegium Pharmaceutical. “Formulations that are designed to be more resistant to physical methods of tampering are an important component in attempting to decrease the growing abuse associated with prescription extended release opioids.”

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 previously reported receipt of Fast Track Designation for the product from the FDA.

About DETERx™

DETERx™ 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™ platform consists of a multiparticulate 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 multiparticulate 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™ product candidates in development for the treatment of pain and ADHD.

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.