AUGUST 12, 2013 TO AUGUST 13, 2013

Meeting Background:

The purpose of this meeting, hosted by CTTI, is to facilitate a broad scientific discussion about optimal ways to generate additional evidence to help inform the safe and effective use of extended-release and long-acting opioid analgesics.

Meeting Objectives:

• Engage multiple stakeholders in discussions around approaches to develop more evidence on the long-term safety and efficacy of extended-release and long-acting opioid analgesics for the treatment of chronic non-cancer pain
• Review and discuss a proposed study to evaluate the long-term efficacy of opioids for the treatment of chronic non-cancer pain
• Discuss strategies to assess the long-term safety of extended-release and long-acting opioid analgesics for the treatment of chronic non-cancer pain

Meeting Location:

Sheraton Silver Spring Hotel, Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

• Welcoming Remarks by Pamela Tenaerts and Rachel Sherman

Session 1: Evidence for the Efficacy of Opioid Analgesics for Chronic Pain

• Review of the Evidence for the Efficacy and Effectiveness of Opioid Analgesics for Chronic Pain by Jane Ballantyne

Session 2: Review of Proposed Efficacy Study

• Overview of Efficacy Protocol Synopsis by Robert Califf
• Proposed Protocol Synopsis (PDF)

Session 3: Continued Discussion of Efficacy Study

Session 4: Existing Data Sources to Evaluate Opioid Analgesic Safety

• Monitoring Opioid Analgesic Abuse and Overdose in the United States by Christopher M. Jones
• Postmarketing Surveillance of Prescription Drug Abuse by Richard Dart
• Harnessing National Data Sets: National Survey on Drug Use and Health (NSDUH) and VA Data by William Becker
• Using Integrated Health Plan EMR Data to Evaluate Outcomes Associated with Clinical Services for the Treatment of Non-Malignant Chronic Pain by Lynn DeBar

Session 5: Gathering Additional Evidence on Opioid Analgesic Safety