Embeda, Oxycontin Might Get Abuse-Deterrent Claims With Post-Marketing Trials

FDA advisory panel will consider design of epidemiological or observational studies to determine if drugs' abuse-deterrent properties are effective.

A two-day, joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees will consider the design of post-marketing studies for Purdue Pharma's Oxycontin and King Pharmaceuticals' Embeda to determine if their product-specific properties intended to discourage misuse and abuse are effective.

Both Oxycontin (oxycodone hydrochloride controlled-release) and Embeda (morphine sulfate extended-release with a sequestered naltrexone hydrochloride inner core) are approved for management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extensive period.

The post-marketing studies are intended to be epidemiological or observational trials to assess the drugs' known serious risks as well as whether their abuse deterrent properties "actually result in a decrease" of abuse and misuse as well as curtailing their potential consequences - addiction, overdose and death, according to FDA.

FDA is happy to see the development of potentially safer opioids, but the agency has been loathe to give the products a claim for abuse deterrence, since simply engineering the pills not to be enjoyed doesn't prove they will work that way, and a controlled trial couldn't ethically have misuse as a endpoint.

The advisory committee meeting, set for Oct. 21 and Oct. 22 in Gaithersburg, Md., is a signal, though, that the agency may consider allowing different kinds of data to support risk reduction language in the label.

Getting The Message Out With A REMS

Having an abuse reduction claim or even just robust data in labeling would be a great benefit for either product, particularly as the agency may be pushing all sponsors to shift their promotional efforts to a risk and education message as part of a potential class-wide Risk Evaluation and Mitigation Strategy for long-acting and extended-release opioids.

In July, the agency issued a proposed REMS for long-acting opioids, to consist of a MedGuide, requirements for drug sponsors to provide prescriber education, requirements for educational sheets to be offered to patients, and a program and timetable for assessing the plan's effectiveness (Also see "FDA's Opioid REMS Proposal Has Narrow Focus On Education" - Pink Sheet, 5 Jul, 2010.).

But the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees voted against approval of the FDA proposal by 10-25 on July 22. Panel members cited concerns that prescriber participation in the educational programs would be voluntary rather than mandatory.

The panel also considered an industry proposal for an opioids REMS during that meeting, suggesting that if prescriber education be mandatory, implementation be through either a third-party industry-wide registry or a Drug Enforcement Administration registry that would require approval by Congress. Industry participants indicated they probably would prefer the latter option (Also see "If Opioid REMS Mandates Prescriber Training, Firms May Ask DEA For Help" - Pink Sheet, 2 Aug, 2010.).

-Joseph Haas ([email protected])