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“Patients with Chronic Pain and Dysphagia (CPD): Unmet Medical Need and Pharmacologic Treatment Options,” Published in Current Medical Research and Opinion

October 7, 2014 at 11:35 AM EDT

Canton, MA – October 7, 2014 – Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain, today announced the publication of “Patients with Chronic Pain and Dysphagia (CPD): Unmet Medical Need and Pharmacologic Treatment Options,” in the peer-reviewed medical journal, Current Medical Research and Opinion.

Dr. Charles Argoff, an internationally recognized pain specialist and lead author on the publication, stated “This manuscript identifies CPD as a significant unmet medical need. There need to be improved treatments for patients with moderate-to-severe chronic pain with dysphagia (CPD). Many of these patients receive sub-optimal pain therapy due to the limitations of currently available medications. They are prone to crushing their extended-release opioid analgesics in order to facilitate swallowing, which is unsafe and can potentially lead to serious side effects. New abuse-deterrent opioid formulations are in development, which appear to have the potential to provide analgesia, but also to offer multiple methods of oral administration, which can be beneficial for these patients.”

The treatment options for patients with CPD are limited. Many of these patients cannot swallow a pill and those patients with more severe dysphagia may require the use of a feeding tube. Long-acting, extended-release (ER) oral opioids are a recommended treatment for many patients with moderate-to-severe chronic pain due to less frequent dosing and more consistent plasma concentrations than immediate-release opioids, thereby minimizing end-of-dose breakthrough pain, providing longer pain control, and providing improved night time pain control. Currently available ER oral opioids (e.g., OxyContin® and OPANA®ER) cannot be crushed to facilitate swallowing or administered via a feeding tube and carry a warning statement to this effect: “Instruct patients to swallow the tablet intact. Crushing, dissolving, or chewing the tablet can cause a rapid release and absorption of a potentially fatal dose of (active ingredient).”

There are currently no approved, abuse-deterrent ER opioid products for the CPD patient population, which consists of over 11 million patients in the U.S. These patients struggle with less than optimal treatments for their chronic pain in part because they cannot swallow or have difficulties swallowing solid, oral dosage forms. Patients with CPD are currently prescribed “workarounds” such as immediate-release opioids or transdermal patches that have certain treatment limitations, which can complicate therapy. Upon FDA approval, Oxycodone DETERx® would potentially be the only abuse-deterrent, ER opioid that could be administered as a sprinkle directly into the mouth or onto soft food, and could also be administered through an enteral feeding tube,” said Dr. Ernest Kopecky, Vice President of Clinical Development for Collegium and co-author of the manuscript.

A copy of the publication is available at: http://informahealthcare.com/doi/abs/10.1185/03007995.2014.967388.

About DETERx® Technology

The DETERx® drug delivery platform consists of a microsphere-in-capsule formulation. While developed primarily to provide abuse-deterrent properties to protect against common methods of tampering such as chewing, crushing, insufflation, and extraction for IV injection, the microsphere design is expected to enable patients with difficulty swallowing to open the capsule and administer the contents onto food or via an enteral tube, while maintaining the ER properties of the product. The DETERx® technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have a narrow therapeutic index that would benefit from protection against misuse such as breaking, crushing, grinding, or dissolving the product. The formulation platform is covered by U.S. and international patents and patent applications. Oxycodone DETERx® is the first of a number of product candidates using the DETERx® platform.

About Collegium Pharmaceutical, Inc.

Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx® formulation platform for the treatment of chronic pain. The DETERx®oral drug delivery technology provides ER delivery, unique abuse-deterrent properties, and flexible dose administration options. For more information, visit the Company’s website at www.collegiumpharma.com.