The FDA is planning to add immediate-release (IR) opioids to its existing opioid Risk Evaluation and Mitigation Strategy (REMS) program, which since its inception five years ago has been focused solely on extended-release/long-acting (ER/LA) opioids. 

Scott Gottlieb, MD, commissioner of the FDA, announced the decision to update the REMs program at the start of a two-day meeting on addressing abuse-deterrent opioids, as first reported by MedPage Today.

The FDA cited the continuing problems of opioid abuse, misuse, addiction and overdose as a key reason for the decision, and highlighted the importance of “approaching all opioid analgesics with adequate knowledge of risk and benefit,” according to the presentation material.

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One reason for adding IR analgesic opioids to the REMS now, according to the materials, is that the existing infrastructure is already in place, adding that “a modified blueprint that focuses on pain management could include education components relevant to ER/LA and IR products.” The FDA was initially met with some criticism from stakeholders who believed the REMS should have included IR drugs from its inception. 

The REMS program is currently monitoring about 34 ER/LA opioid analgesic companies and 65 ER/LA opioid analgesic New Drug Applications. The FDA said approximately 50 companies will be expected to participate in the REMs program for IR opioids.

The existing REMS, which was put into place on July 9, 2012, requires ER/LA opioid analgesic companies to include available training for health care professionals who prescribe ER/LA opioid analgesics on proper prescribing practices and to distribute educational materials to prescribers and patients on the safe use of these pain medications.

—Michael DePeau-Wilson