Opioid Drug Approvals (2009)
In July and August 2009, FDA approved two new opioid drugs with REMS. Onsolis, a short-acting opioid to manage breakthrough pain, was approved for patients with cancer who already use pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. FDA required a REMS with Onsolis, because it is a drug that can lead to overdose, sudden serious breathing difficulties, and death. The REMS for Onsolis was specifically tailored to the drug and is not intended to be a model for the long-acting opioid REMS.
FDA also approved Embeda in August with a REMS that includes a Medication Guide. Embeda is a long-acting opioid for the management of moderate to severe pain when a continuous, around-the-clock opioid is needed for an extended period of time. Once FDA determines what REMS elements should be implemented across the class of modified-release opioids, Embeda’s REMS will be modified to incorporate those elements. FDA will continue to review new drug applications for opioids while developing the requirements for REMS for long-acting opioids.