Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved a Prior Approval Supplement for Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release capsules CII.

The Prior Approval Supplement included an update to the Embeda manufacturing process that addressed the pre-specified stability requirement that led to the voluntary recall of Embeda from the market in March 2011.  Pfizer anticipates product availability in the second quarter of 2014.

Embeda is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Embeda is not for use as an as-needed (prn) analgesic, for pain that is mild or not expected to persist for an extended period of time, for acute pain, for postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time

Embeda 100mg/4mg capsules are only for patients in whom tolerance to an opioid of comparable potency is established.

Embeda contains pellets of morphine sulfate, an opioid agonist, with a sequestered core of naltrexone hydrochloride, an opioid receptor antagonist.  Morphine sulfate is a Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient’s risk for opioid abuse or addiction prior to prescribing Embeda. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving Embeda for signs of misuse, abuse, and addiction during treatment.