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

ock-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
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SOURCE Collegium Pharmaceutical, Inc.
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