The Return of Embeda®

by Alan Rook
PharmD, Clinical Pharmacist

It’s Baaack…Embeda®

Embeda® will be back in the marketplace on January 26, 2015, after the manufacturer voluntarily recalled the drug almost 4 years ago.

On October 17, 2014, the FDA approved new labeling for Embeda® (morphine sulfate and naltrexone hydrochloride) extended-release capsules indicated for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.  At the time of this approval, Embeda® was the third opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, “Guidance for industry: Abuse-Deterrent Opioids – Evaluating and Labeling”–which explains to industry how studies should be conducted to demonstrate abuse deterrent properties, how those studies would be evaluated, and what claims can be made based on outcomes of those studies.

Embeda® abuse deterrent opioid

Embeda® was initially approved by the FDA on August 13, 2009.

Unfortunately for Pfizer, which acquired King Pharmaceuticals in 2010, Embeda® was voluntarily recalled from the market in March 2011 because of manufacturing issues regarding stability requirements.  In November 2013, the FDA approved a Prior Approval Supplement, including an update to the manufacturing process to address the stability requirements–and then, as previously stated, the FDA approved the new labeling to include abuse-deterrent studies which claim abuse reduction.

Embeda® as an abuse-deterrent

The FDA stated when it released its 2013 draft guidance that they would “encourage the development of abuse-deterrent formulations of opioids and believes that these products have promise to help reduce prescription drug abuse.”  The FDA has kept their word with multiple approvals in 2014, with the exception of Zohydro®, a long-acting non-abuse deterrent hydrocodone bitartrate approved in October 2013.

It appears the FDA has provided an environment that is favorable for the manufacturers of opioid analgesics with abuse-deterrent formulations.  Pfizer, the manufacturer of Embeda®, is all-in, stating that they support “the appropriate use of opioid pain medications and has other products in development incorporating abuse deterrent technology.”  Oh joy.  Pfizer must be feeling pretty good with this re-introduction because they have “decided to remove its non-abuse deterrent morphine formulation, Avinza® (morphine sulfate) extended release capsules from the U.S. market and notified the FDA with its plans to discontinue the manufacturing of the product.”

Reducing the availability and use of opioids seems to be a logical approach and yet it appears the opposite is happening.

Even when taken orally, all the long-acting “abuse-deterrent” opioids still have the potential for abuse if they are not taken as directed.  I can’t help but be skeptical of all these new opioid “abuse-deterrent” formulations hitting the marketplace.  In my opinion, these extremely harmful medications are simply being “re-packaged,” along with the financial security of new patents.

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