Approved August of 2009
moderate to severe pain
Embeda is an extended-release oral formulation of morphine sulfate and naltrexone hydrochloride. Morphine sulfate is an agonist and naltrexone hydrochloride is an antagonist at the mu-opioid receptor. Morphine provides analgesic and sedative effects while naltrexone hydrochloride reverses the subjective and analgesic effects.
Embeda is specifically 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 supplied as a capsule intended for oral administration. The recommended dosing regimens are as follows:
Initiating therapy with Embeda
The dosing regimen should be calculated individually, taking into account the patient's prior analgesic treatment experience.
Use of Embeda as the First Opioid Analgesic
The lowest dose of Embeda should be used as the initial opioid analgesic. Patients may subsequently be titrated to a once or twice a day dosage which adequately manages their pain.
Conversion from Other Oral Morphine Formulations to Embeda
Patients on other oral morphine formulations may be converted to Embeda by administering one-half of the patient's total daily oral morphine dose as Embeda every 12 hours (twice-a-day) or by administering the total daily oral morphine dose as Embeda every 24 hours (once-a-day). Embeda should not be given more frequently than every 12 hours.
Conversion from Oral Opioids, Parenteral Morphine, or Other Parenteral Opioids to Embeda
Embeda can be administered to patients previously receiving treatment with parenteral morphine or other opioids.
1) Parenteral to Oral Morphine Ratio: It may take anywhere from 2-6 mg of oral morphine to provide analgesia equivalent to 1 mg of parenteral morphine.
2) Other Oral or Parenteral Opioids to Oral Morphine Sulfate: There is lack of systematic evidence bearing on these types of analgesic substitutions. Therefore, specific recommendations are not possible.
Individualization of Dosage
Patients may develop some degree of tolerance, requiring dosage adjustment until they have achieved their individual balance between effective analgesia and opioid side effects such as confusion, sedation, and constipation.
Alternative Methods of Administration
Patients who have difficulty swallowing whole capsules or tablets may benefit from an alternative method of administration. Embeda pellets may be sprinkled over apple sauce. Other foods have not been tested and should not be substituted for apple sauce.
Maintenance of Therapy
Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy.
Cessation of Therapy
In general, Embeda should not be abruptly discontinued. However, Embeda, like other opioids, can be safely discontinued without the development of withdrawal symptoms by slowly tapering the daily dose.
The FDA approval of Embeda was based on a randomized, double-blind, placebo-controlled clinical trial. This study, ALO-KNT-301, enrolled subjects with moderate to severe osteoarthritic pain of the hip or knee. The subjects started open-label treatment with Embeda and titrated to effect. Once their pain was controlled (Brief Pain Inventory Average 24-hour Pain Intensity AND at least a 2-point drop from screening baseline), they were randomized to either active treatment with Embeda or were tapered off Embeda using a double-dummy design and placed on placebo. Of these, 75.1% of the randomized subjects were opioid naïve and distributed evenly between the 2 groups. The mean change in the weekly diary BPI average pain score from randomization baseline (Visit Y) to the end of study (Visit Y + 12 Weeks/Early Termination) was statistically significantly superior for those treated with Embeda compared to the placebo group.
Ongoing Study Commitments
Adverse reactions associated with the use of Embeda may include, but are not limited to, the following:
Embeda is an extended-release oral formulation of morphine sulfate and naltrexone hydrochloride. Morphine sulfate is an agonist and naltrexone hydrochloride is an antagonist at the mu-opioid receptor. Morphine produces both its therapeutic and its adverse effects by interaction with one or more classes of specific opioid receptors located throughout the body. Morphine acts as a pure agonist, binding with and activating opioid receptors at sites in the periaqueductal and peri-ventricular grey matter, the ventro-medial medulla and the spinal cord to produce analgesia. Naltrexone is a pure, centrally acting mu-opioid antagonist that reverses the subjective and analgesic effects of mu-opioid receptor agonists by competitively binding at mu-opioid receptors.
For additional information regarding Embeda or moderate to severe pain, please visit the Embeda web page.
The Embeda (morphine sulfate and naltrexone hydrochloride) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.