Encouraging manufacturers to develop opioid products that are formulated to deter abuse is one of the main goals of a new draft guidance released Jan. 9 by the Food and Drug Administration.
"Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling" provides information for companies interested in developing formulations of opioids with potential abuse deterrent properties, Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said at a briefing.
The document explains the agency’s views on the types of studies that should be conducted to show that a product can deter abuse, how those studies will be evaluated by the agency, and what labeling claims would be allowed based on the results of the FDA’s evaluations of those data. The ability to add abuse deterrent claims to a product’s label is expected to encourage companies to develop these products, he said.
The technology of formulations that deter abuse and the clinical epidemiology and statistical methods used to evaluate the potential of such products for abuse deterrence is a relatively new area of research, and the FDA plans "to take a flexible approach" in evaluating these products as the science evolves, Dr. Throckmorton said.
During the briefing, he pointed out that the guidance is one of the components of the FDA’s effort to prevent prescription drug abuse and misuse, "while ensuring patients in pain continue to have access to these medicines." In 2009, almost 425,000 visits to emergency departments involving nonmedical or inappropriate use of opioids and an estimated 15,600 deaths in the United States were attributed to opioid products, he said.
This draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act and the Office of National Drug Control Policy’s Prescription Drug Abuse Prevention Plan.
The FDA statement announcing the guidance explains that abuse deterrent formulations "target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation" and that the agency believes these formulations have "promise to help reduce prescription drug abuse."
Two opioid products with abuse deterrent formulations are currently available: Since 2010, OxyContin (controlled-release oxycodone) has been available in a formulation that prevents it from being chewed, crushed, or dissolved. A crush-resistant formulation of hydromorphone (Opana ER) was approved in September 2012. But the prescribing information for these products do not include claims regarding abuse deterrence properties.
The lack of abuse deterrent features was the main reason an FDA advisory panel recommended against approval of an extended-release, single-ingredient capsule formulation of hydrocodone at a meeting in December. Without such a feature, the product would quickly become widely abused once it was approved and marketed, some of the panelists predicted.
The FDA plans to hold a public meeting to discuss public feedback on the draft guidance.
During the briefing, Dr. Throckmorton said that the FDA had not yet decided what to do about generic formulations of opioids that have no abuse deterrent properties.
The guidance "is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse," and the agency is "extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation," FDA commissioner Dr. Margaret Hamburg said in the statement.
Comments and suggestions can be submitted to the FDA within 60 days of publication in the Federal Register, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852, with the docket number listed.