The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, Abuse-Deterrent Opioids – Evaluation and Labeling. The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral abuse when the product is crushed.

Embeda has properties that are expected to reduce, but not totally prevent, abuse of the drug when crushed and taken orally or snorted. Embeda works by releasing only the morphine in the capsule when taken properly. When crushed, the naltrexone in Embeda blocks some of the euphoric effects of the morphine and can precipitate withdrawal in persons dependent on opioids.

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm419288.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery