Government and Regulations

FDA approves extended-release hydrocodone with abuse-deterrent features




An extended-release formulation of hydrocodone with properties that are “expected to reduce, but not totally prevent” abuse has been approved, the Food and Drug Administration announced on Nov. 20.

The hydrocodone-only product is indicated for treating pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the FDA statement. It is not approved for as-needed pain relief, and because of its risks for abuse, misuse, and addiction, “should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management,” the FDA statement said.

The product will be marketed as Hysingla ER, by Purdue Pharma, the manufacturer of extended-release oxycodone marketed as OxyContin.

Hysingla ER comes in 20-mg, 30-mg, 40-mg, 60-mg , 100-mg, and 120-mg strengths, taken once a day; daily doses of 80 mg or more should not be prescribed to people who have not previously been treated with an opioid. These amounts are higher than immediate-release hydrocodone combination products, but the range is “comparable” to currently available extended-release opioids, the statement points out.

The tablet has properties that make it difficult to crush, break, or dissolve. It also forms a thick gel when put in liquid, which “resists passage through a hypodermic needle,” according to the prescribing information. While the product’s physical and chemical properties are expected to make abuse by these routes difficult, abuse by these routes is still possible, the FDA statement said.

As part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids, Purdue is required to provide health care professionals with information on how to safely prescribe the drug and to provide documents to patients, including a medication guide with each prescription, about how to safely use, store, and dispose of these products.

The company is also required to conduct postmarketing studies to evaluate the impact of the abuse-deterrent properties on the risk of abuse and the impact of that abuse in the community, according to the statement.

“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the statement. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain,” she added.

In October, hydrocodone was switched from a schedule III to the stricter schedule II category.

Hysingla ER is expected to be available in early 2015, according to a statement by Purdue.

In August 2014, hydrocodone was switched from a schedule III to a schedule II controlled substance.

The prescribing information is available at

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