Strategies to Gather Evidence on the Long-Term Safety and Efficacy of Extended-Release and Long-Acting Opioid Analgesics
Opioids are prescribed for pain management, but these drugs are often misused and/or abused, which can lead to addiction, adverse events, or deaths from accidental or intentional overdoses. Extended-release (ER) and long-acting (LA) opioids contain large amounts of drug in a single dose and have an especially high potential for misuse and abuse. In this collaborative project, CTTI’s primary focus was to facilitate a broad scientific discussion about potential ways and best practices to generate evidence to inform the safe use of ER and LA opioid analgesics for the treatment of chronic non-cancer pain. An expert meeting was held to review the existing scientific evidence and discuss next steps to generate higher quality data on the safety and efficacy of long-term opioid use.
Project Status: Closed
In March 2013, the FDA released an open letter to US prescribers to inform them of the alarming rate of misuse and abuse of prescription opioids in the US and urge them to participate in opioid prescribing training. While much of opioid abuse is attributable to illicit use, appropriate use of pain medications can also lead to unnecessary adverse events, addiction, and death. In particular, extended-release (ER) and long-acting (LA) opioids, which contain large amounts of drug in a single dose, have a high potential for misuse and abuse. OxyContin (oxycodone hydrochloride controlled-release) and Dolophine (methadone hydrochloride) are two examples of ER/LA opioid drug products that have received public attention due to overdoses associated with their use.
In addition to the serious issues of accidental or intentional overdoses and the potential development of addiction, there was a lack of safety and efficacy data supporting long-term use of opioid products.
Long-Term Opioid Data: “Strategies to Gather Evidence on the Long-Term Safety and Efficacy of Extended-Release and Long-Acting Opioid Analgesics” (2013-2014)
Existing scientific evidence was reviewed at a CTTI expert meeting. Evidence of the short-term efficacy of opioids to decrease nociceptive and neuropathic pain was available, but there was a lack of quality evidence on the long-term efficacy of opioids in the setting of chronic pain. Some data correlate long-term use of opioids in chronic pain with poorer clinical outcomes. It was noted that safety outcomes from clinical trials are not necessarily generalizable to the overall chronic pain population because data was collected from narrow pain populations, excluding patients at greater risk for adverse events (those on higher opioid doses), with mental health comorbidities, and at high risk of addiction. Because a limited dataset was used to draw these conclusions, still more evidence is needed.
Experts discussed the available data on opioid use in the context of a protocol for a randomized clinical trial. Attendees of the meeting agreed that a protocol to evaluate long-term opioid efficacy was generally a step in the right direction; however, several practical limitations needed to be addressed before moving forward with a pilot protocol.