HealthDay News — The FDA has issued draft guidelines to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.
“The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation,” FDA Commissioner Margaret A. Hamburg, MD, said in a press release. “This draft guidance is an important part of a larger effort by [the] FDA aimed at preventing prescription drug abuse and misuse.”
The document details the FDA’s current thinking about the studies that should be done to demonstrate abuse-deterrent properties in a given formulation, how those studies will be evaluated by the FDA, and what labeling claims may be approved based on study results.
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The draft guidelines fulfill mandates under the FDA’s Safety and Innovation Act (FDASIA) and the Office of National Drug Control Policy’s (ONDCP) Prescription Drug Abuse Prevention Plan, the agency explained.
The number of tamper-resistant opioid medications in development is unclear, but many companies with brand-name opioid products have introduced abuse-resistant versions, such as Purdue’s OxyContin (oxycodone) and Endo’s Opana (oxymorphone), in efforts to deter generic versions that do not have the same technology.
Generic opioid formulations will not be covered by the new guidelines, nor will other immediate-release generic opioids currently on the market.
The current U.S. opioid painkiller “epidemic” is the main driving factor in efforts to develop abuse-deterrent medications. Newer formulations make it harder for users to tamper with opioids by crushing, chewing, or injecting them, but not much can be done about “the most common form of abuse — swallowing a number of intact pills or tablets,” the FDA noted in the guidelines.
After a 60-day public comment period, the FDA will convene a public hearing to discuss the guidelines and concerns.
