The FDA has approved new labeling to highlight the abuse-deterrent properties of extended-release Embeda (morphine sulfate and naltrexone hydrochloride), an oral opioid analgesic indicated for pain that requires daily, 24-hour treatment.
“Embeda has properties that are expected to reduce, but not totally prevent, abuse of the drug when crushed and taken orally or snorted,” the agency said in a press release. When taken as indicated in capsule form, the drug releases only morphine. When crushed, however, it releases naltrexone, which partially inhibits the morphine’s effects and can lead to withdrawal symptoms in opioid-dependent patients.
Embeda still has the potential to be abused when taken in capsule form, the FDA cautioned. The agency is requiring postmarketing studies to more fully evaluate its abuse-resistant properties.