Regulators are currently meeting to delve into specifics about the evaluation and regulation of abuse-deterrent opioids. At the off-site public meeting in Silver Spring, Md., representatives from the FDA and the pain therapeutics industry will drill down into the draft guidance for abuse-deterrent opioids that was released in January 2013. The FDA said it is not ready to banish non-abuse-deterrent opioid formulations from the market: “We have said that a class-wide requirement is not feasible or in the interests of public health at this time,” the agency wrote in a Federal Register notice. It said it will continue to take a case-by-case approach to approval “with a goal of incentivizing an incremental, sponsor-driven market transition from conventional opioid formulations to formulations with meaningful abuse-deterrent properties.” But the agency did give some signal that it may eventually call for all opioids to have abuse-deterrent properties.
Read the full details from MedPage Today here.