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The Food and Drug Administration has approved new labeling for the opioid analgesic Embeda to include information about the drug’s abuse-preventive properties, the agency announced Oct. 17.
The extended-release morphine sulfate and naltrexone hydrochloride tablets are used to treat severe, long-term pain resistant to alternative treatment options. Embeda acts as an abuse deterrent by releasing morphine only when taken properly as a whole capsule, and not when crushed or snorted, the FDA said in a statement.
“When crushed, the naltrexone in Embeda blocks some of the euphoric effects of the morphine and can precipitate withdrawal in persons dependent on opioids,” according to the announcement.
However, the drug can still be abused when taken as a whole capsule, because the naltrexone does not effectively block the euphoric morphine effects when consumed properly, the FDA said. Such misuse could result in overdose or death, FDA officials added. It is still unknown whether intravenous administration also would have abuse-deterrent properties.
Embeda was first approved in 2009, but was temporarily withdrawn from the market in 2011 because of “stability concerns” found in the manufacturing process. According to the FDA, that issue was resolved in November 2013 with the approval of a manufacturing supplement.
Because of its highly addictive nature, Embeda is not approved for as-needed pain relief, and should only be used in severe cases when pain cannot be effectively managed by other means, the agency said in the statement.
The new labeling is consistent with the FDA’s 2013 draft guidance. Embeda is the third extended-release opioid analgesic to include a label describing its abuse-deterrent properties.
Embeda is marketed by Pfizer.
For more information on opioid medications, please visit www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm.
The Food and Drug Administration has approved new labeling for the opioid analgesic Embeda to include information about the drug’s abuse-preventive properties, the agency announced Oct. 17.
The extended-release morphine sulfate and naltrexone hydrochloride tablets are used to treat severe, long-term pain resistant to alternative treatment options. Embeda acts as an abuse deterrent by releasing morphine only when taken properly as a whole capsule, and not when crushed or snorted, the FDA said in a statement.
“When crushed, the naltrexone in Embeda blocks some of the euphoric effects of the morphine and can precipitate withdrawal in persons dependent on opioids,” according to the announcement.
However, the drug can still be abused when taken as a whole capsule, because the naltrexone does not effectively block the euphoric morphine effects when consumed properly, the FDA said. Such misuse could result in overdose or death, FDA officials added. It is still unknown whether intravenous administration also would have abuse-deterrent properties.
Embeda was first approved in 2009, but was temporarily withdrawn from the market in 2011 because of “stability concerns” found in the manufacturing process. According to the FDA, that issue was resolved in November 2013 with the approval of a manufacturing supplement.
Because of its highly addictive nature, Embeda is not approved for as-needed pain relief, and should only be used in severe cases when pain cannot be effectively managed by other means, the agency said in the statement.
The new labeling is consistent with the FDA’s 2013 draft guidance. Embeda is the third extended-release opioid analgesic to include a label describing its abuse-deterrent properties.
Embeda is marketed by Pfizer.
For more information on opioid medications, please visit www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm.
The Food and Drug Administration has approved new labeling for the opioid analgesic Embeda to include information about the drug’s abuse-preventive properties, the agency announced Oct. 17.
The extended-release morphine sulfate and naltrexone hydrochloride tablets are used to treat severe, long-term pain resistant to alternative treatment options. Embeda acts as an abuse deterrent by releasing morphine only when taken properly as a whole capsule, and not when crushed or snorted, the FDA said in a statement.
“When crushed, the naltrexone in Embeda blocks some of the euphoric effects of the morphine and can precipitate withdrawal in persons dependent on opioids,” according to the announcement.
However, the drug can still be abused when taken as a whole capsule, because the naltrexone does not effectively block the euphoric morphine effects when consumed properly, the FDA said. Such misuse could result in overdose or death, FDA officials added. It is still unknown whether intravenous administration also would have abuse-deterrent properties.
Embeda was first approved in 2009, but was temporarily withdrawn from the market in 2011 because of “stability concerns” found in the manufacturing process. According to the FDA, that issue was resolved in November 2013 with the approval of a manufacturing supplement.
Because of its highly addictive nature, Embeda is not approved for as-needed pain relief, and should only be used in severe cases when pain cannot be effectively managed by other means, the agency said in the statement.
The new labeling is consistent with the FDA’s 2013 draft guidance. Embeda is the third extended-release opioid analgesic to include a label describing its abuse-deterrent properties.
Embeda is marketed by Pfizer.
For more information on opioid medications, please visit www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm.
