Abuse Resistant Morphine Approved by the FDA

On October 17, 2014, the US FDA Approved Abuse Deterrent Labeling for Embeda® (morphine sulfate and naltrexone hydrochloride) Extended-Release (ER) Capsules.

Embeda® is the first and only approved ER morphine specifically designed to deter oral and intranasal abuse when crushed. The updated label states that Embeda has properties that are expected to reduce abuse via the oral and intranasal (i.e., snorting) routes when crushed.

Embeda® is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Manufactured by Pfizer laboratories, Embeda® is not expected to be released until early 2015.

As was discussed with the approval of Targiniq ER® (Oxycodone/Naloxone) back in July, only time will tell if Embeda® begins to appear on claims payment histories and if it will be somehow abused once post-marketing surveillance and follow-up begins.

With the recently released news that over 92,000 overdoses in Emergency rooms are attributed to opioids and the re-classification of Hydrocodone to CII status, will medications like Embeda® and Targiniq ER® become the norm or are we just a little too late in combating this epidemic on opioid abuse? Again, only time will tell.

The links to the FDA press release concerning Embeda® and the study on emergency room overdoses can be found below:

http://www.latimes.com/science/sciencenow/la-sci-sn-opioid-overdose-prescription-hospital-er-20141026-story.html

http://www.pfizer.com/news/press-release/press-release-detail/fda_approves_abuse_deterrent_labeling_for_embeda_morphine_sulfate_and_naltrexone_hydrochloride_extended_release_er_capsules_cii

References

  1. E-Facts and Comparisons. Clinical Drug Information, LLC 2014
  2. FDA Press Release Embeda® Pfizer 2014.

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