Purdue Pharma Petitions FDA to Apply ER/LA Requirements to IR Opioid Analgesics

By Alexander J. Varond –

Purdue Pharma recently submitted a citizen petition challenging FDA’s decision to require labeling revisions and postmarket study requirements for extended-release and long acting opioid analgesic products but not immediate-release products. We discussed these revisions here.

Purdue’s citizen petition, dated February 11, 2014, requests that the FDA undertake two actions:

Seek and, if necessary, impose safety labeling changes on immediate-release opioid analgesics that parallel the final safety labeling changes resulting from completion of the 505(o) procedures initiated on September 10, 2013 for extended-release and long-acting opioid analgesics. Assure that the indications for use and other safety labeling information for immediate-release and extended-release and long-acting opioid analgesics convey the same warnings and precautions regarding the risks of opioid use and misuse.

Recall that, as Purdue highlights in its citizen petition, FDA’s rationale for its disparate treatment of ER/LA and IR opioids was:

that there are disproportionate safety concerns associated with these products compared to immediate-release (IR) opioids. For example, data show that the risk for misuse and abuse is greater for ER/LA opioids. . . . Further, because they are intended to release the drug over a longer period of time, many ER/LA opioids contain higher doses of opioids compared to IR opioids or opioid non-opioid combinations. This may make certain ER/LA opioids more desirable in the eyes of opioid abusers and addicts, and increases the risk of a fatal outcome in the event of an overdose.

Purdue argues that this disparate treatment is “contrary to public health and inconsistent with available data evaluating the respective risks of these medications.”

The citizen petition cites a number of sources to support its assertion that IR opioids are “associated with the same potential adverse consequences as ER/LA opioids.” The sources include data from a commercial insurance claims database, poison centers, substance-use-disorder treatment centers, and a national prescription database. Purdue also argues that FDA inaccurately represented the DAWN data, which had served as important support for FDA’s rationale for the disparate treatment of LA/ER and IR opioid products.

Purdue contends that even if there are demonstrable differences in degree between the risks posed by ER/LA and IR opioids, the risk are not different in kind or in the any other relevant respect. The citizen petition also notes that FDA’s actions could move patients to higher doses or longer courses of IR opioid analgesics, which could increase the opportunity for diversion and negatively impact public health.

If FDA grants Purdue’s citizen petition, IR opioid analgesics labeling would need to better communicate risks of the products and encourage careful prescribing, patient counseling, and monitoring. It might also open the door for postmarket study requirements to generate data to assess risks of IR opioid misuse, abuse, addiction, overdose, and hypersensitivity to pain, as well as potentially encouraging the development of class-wide REMS for IR opioids (see our post on ER/LA class-wide REMS here).