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Abuse-deterrent opioid analgesic Embeda® expected to be discontinued from the market

by
Clinical Connection team
| Oct 29, 2019

The U.S. Food and Drug Administration (FDA) reports that sales for the abuse-deterrent opioid analgesic, Embeda® (morphine sulfate and naltrexone extended-release capsules), manufactured by Pfizer Pharmaceuticals, will cease on November 15, 2019. According to the FDA’s website and with the current stock available, Embeda is expected to be unavailable in early 2020. At this time, no additional information was provided on Pfizer’s website related to its business decision to discontinue selling this medication.

Guidance for claimants prescribed Embeda
If a claimant is prescribed Embeda, their prescriber should review their current medication therapy over the next several weeks to determine if ongoing opioid analgesic therapy is required. If pain management is still necessary, an alternative treatment should be considered.

Embeda is a long-acting opioid analgesic indicated for the management of chronic severe pain in patients who require daily, around-the-clock opioid treatment. It was first approved by the FDA in 2009 and redeployed in six different abuse-deterrent strengths in 2015. There are currently no generic formulations available.

Impact on workers’ compensation
Upon review of our transactional data, there was a minimal impact on our book of business. We will be providing impact assessments to our clients through our account managers and clinical liaisons.

To access the FDA Drug Shortages website and company contact information, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.


Sources:

  1. U.S. Food and Drug Administration (FDA). FDA Drug Shortages. Current and Resolved Drug Shortages and Discontinuations Reported to FDA. Morphine Sulfate and Naltrexone Hydrochloride (EMBEDA®) Extended-Release Capsules. October 7, 2019. Available at: https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

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