August 13 – The FDA has approved a new drug designed for steady around-the-clock relief of moderate to severe pain that combines extended release morphine sulfate with the opioid antagonist naltrexone (which tends to block the effects of narcotics) – according to a news release from the drug's maker, King Pharmaceuticals.
The point being that the new Schedule II drug (EMBEDA™) would be harder to abuse than other extended-release opioid drugs. If the patient swallows the capsule whole as directed, the morphine is released slowly into the blood stream over time while the naltrexone (embedded within morphine pellets in the capsule) passes through the GI tract unabsorbed.
But if the patient chews, crushes, or dissolves the capsule so that the timed-release effect is lost, the sequestered naltrexone “booby trap” is also released and will work to block the morphine’s effect. (Reportedly, during a one-year safety study, about 11% of the patients’ blood samples contained traces of naltrexone.)
For more information on the drug's trials, prescribing information, and expected availability, click here.