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Significant Unmet Medical Need for Treatment of Patients with Chronic Pain with Dysphagia (CPD)
Date:4/22/2013

CANTON, Mass., April 22, 2013 /PRNewswire/ -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain, today announced the completion of a research study, conducted with an independent market research firm, that identified a significant unmet medical need for improved treatments for patients with chronic pain and dysphagia/odynophagia. In clinical practice, dysphagia is most often defined as difficulty in swallowing and odynophagia is defined as pain upon swallowing. Both conditions may contribute to the inability or difficulty in swallowing solid oral analgesic medications.

Key findings from the research study, which included a review of the medical literature and interviews with physicians who specialize in the treatment of patients with chronic pain, revealed a significant prevalence of dysphagia in this patient population. Chronic pain is a major public health issue in the U.S., affecting approximately 100 million patients. Moreover, approximately 37 million patients suffer from dysphagia. An estimated 11 million people suffer from both chronic pain and dysphagia (Chronic Pain with Dysphagia or "CPD") across a variety of pain subtypes (e.g., chronic back pain, osteoarthritis, and cancer pain). The prevalence of CPD increases with age: 17% of pediatric (0-19 years of age), 24% of adult (20-64 years of age) and 59% of geriatric (>65 years of age) patients.

Treatment options for patients with CPD are limited. Many of these patients cannot swallow a pill and those with more severe dysphagia may require the use of a feeding tube. "Long-acting, extended-release (ER) oral opioids are the treatment of choice for many patients with chronic pain due to less frequent dosing and more consistent plasma concentrations of medication, thereby minimizing end-of-dose breakthrough pain, longer pain control, improved nighttime pain control, and less clock-watching by patients. However, this may not be the case for patients with CPD," said Dr. Ernest Kopecky , Vice President of Clinical Development and Head of Neuroscience at Collegium. Currently available ER oral opioids cannot be crushed to facilitate swallowing or administration via a feeding tube and carry a warning statement: "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)." In addition, some of the newer abuse-deterrent formulations have a product label that includes the warning: "Use with caution in patients who have difficulty swallowing or have underlying GI disorders that may predispose them to obstruction."

For this reason, patients with CPD are primarily treated with fentanyl patches, immediate-release opioids (liquids or crushed), and methadone liquid. Each of these treatment options can have limitations that can complicate therapy. For example, immediate-release opioids need to be administered 4-6 times per day, which can adversely affect patient compliance due to the significant pill burden, provide less effective (consistent) pain control, diminish quality of sleep, and decrease quality of life.

The physicians that were interviewed for this research study expressed a significant interest in the development of an oral ER opioid that can be sprinkled onto food or taken directly by mouth and can be administered via a nasogastric or gastric tube without compromising the ER properties of the analgesic.

"These findings confirm that there is a large number of patients with chronic pain, including pediatric, geriatric, and palliative care patients, suffering from dysphagia that may benefit from an extended-release, abuse-deterrent oral opioid that can be administered as a sprinkle or through a feeding tube," said Michael Heffernan , CEO of Collegium. "We will be publishing the full results of this study shortly."

About DETERx® Technology

The DETERx® drug delivery platform consists of a multi-particulate matrix formulation in a capsule. 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 multi-particulate design is expected to enable patients with difficulty swallowing to open the capsule and administer the contents on food or via a gastronomy tube, while maintaining the extended-release properties of the product. DETERx® technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have narrow therapeutic windows 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. COL-003 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 extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options. For more information, visit the Company's website at www.collegiumpharma.com.

Contact:

Michael Heffernan , President
Collegium Pharmaceutical, Inc.
781-713-3722
mheffernan@collegiumpharma.com


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SOURCE Collegium Pharmaceutical, Inc.
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