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Purdue Pharma L.P. to Present Data pn Long-Term Analgesic Efficacy of Opioid Therapy


9/6/2013 9:12:35 AM

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LAS VEGAS, Sep. 5, 2013 – Purdue Pharma L.P. will present two posters highlighting the potential for long-term opioid therapy to treat patients with chronic non-cancer pain at PainWeek, Sept. 4-7 in Las Vegas.

The posters are scheduled to be presented at the following time:

- Thursday, Sept. 5, 6:15-7:30 p.m. – Poster No. 130 “The Long-term Analgesic Efficacy of Opioid Therapy in Chronic Non-Cancer Pain Patients: A Literature Review of Randomized Controlled, Open Label, and Epidemiologic Studies” R. Matsuno, L. Wallace, L. Alexander, P.Coplan

- Thursday, Sept. 5, 6:15-7:30 p.m. – Poster No. 129 “Long-Term Pain Management with Prescription Opioid Treatment” C. Munera, L. Wallace, C. Landau

The first poster, “The Long-term Analgesic Efficacy of Opioid Therapy in Chronic Non-Cancer Pain Patients: A Literature Review of Randomized Controlled, Open Label, and Epidemiologic Studies” is an analysis of 60 published studies, representing a total of 15,546 patients and 12,904 person-years of opioid treatment experience. The 60 published studies consisted of 46 randomized, controlled trials (RCTs), open-label (OL) studies and open-label extension (OLE) studies as well as 14 epidemiology studies. The clinical studies and the epidemiology studies accounted for 66 percent and 34 percent of the treatment experience, respectively. Of the 46 RCTs, OL studies, and OLE studies, 28 studies (6 RCTs, 14 OL, and 8 OLE studies) reported pain scores over 3-month intervals. The 28 studies were used to assess changes in pain scores within patients from the time before they started the opioid study treatment to 3 months after starting the opioid study treatment, and beyond 3 months to 6 months or 12 months after starting the opioid study treatment.

For all of the 28 studies, a large decrease in reported pain occurred on average within patients from the time before they started the opioid study treatment to 3 months after starting the opioid study treatment. Beyond 3 months on opioid treatment, the reported pain decrease that occurred within patients who remained on opioid therapy during the first 3 months of opioid treatment was generally maintained through 6 and 12 months. Three studies demonstrated that the maintenance of pain score reductions achieved during the first 3 months of opioid treatment was maintained out to 36 months.

The research was subject to several limitations: patient populations, including the pain condition being treated, the severity of pain at baseline, and whether or not patients were opioid naive at the start of the study, varied across studies; the quality of studies was not taken into consideration; instruments to measure pain and functional status varied across studies; a formal meta-analysis was not performed; and the ratings of study outcome(s) were not weighed against the occurrence of adverse events and their severity.

The second poster, “Long-Term Pain Management with Prescription Opioid Treatment” used clinical trial data from 10 chronic non-cancer pain open-label and open-label extension multinational studies of controlled-release opioids conducted between 1998 and 2008 with exposures ranging from 6 months to 3 years to assess maintenance of pain control among a subset of patients who remained on opioid therapy after the randomized, placebo-controlled trials finished.

“Pain is one of the most chronic disabilities, and it is a significant public health issue,” said Gary L. Stiles, M.D., Senior Vice President of Research and Development at Purdue. “We believe this literature review provides additional evidence regarding long-term analgesic effectiveness of opioid therapy as one treatment option for pain patients.”

The research was funded by Purdue Pharma L.P.

About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production and distribution of both prescription and over-thecounter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

Contact:

Jim Heins

Senior Director, Public Affairs

203-588-8069

james.heins@pharma.com

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