The Food and Drug Administration (FDA) has approved new labeling for Embeda (morphine sulfate and naltrexone HCl; Pfizer) extended-release (ER) capsules to include abuse-deterrence studies. Embeda is indicated for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The new abuse-deterrent labeling includes data indicating that the drug has properties that are expected to reduce oral and intranasal abuse when it is crushed, though abuse by these routes is still possible. The label also includes data from a human abuse potential study of IV morphine and naltrexone that mimic the crushed form of Embeda; it is unknown at this time whether the results with simulated crushed Embeda predict a reduction in abuse by the IV route.
Postmarketing studies for Embeda are being required to evaluate the effects of the abuse-deterrent features on the abuse risk for Embeda and its consequences. As part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), the company also needs to provide educational programs on safely prescribing ER/LA opioids and provide Medication Guides and patient counseling documents containing information on its safe use, storage, and disposal.
Embeda was initially approved on August 13, 2009, but was withdrawn from the market in March 2011 following stability concerns in the manufacturing process. In November 2013, the FDA approved a new manufacturing plant with resolution of these issues.
Pfizer anticipates Embeda to be available in early 2015.
For more information call (800) 505-4426 or visit Pfizer.com.