Abuse Deterrent Hydrocodone Approved by the FDA

Over the last several months, we have seen the approval of both Embeda® and Targiniq ER® as abuse deterrent Morphine and Oxycodone formulations.

Today, the FDA approved Hysingla ER® (Hydrocodone Bitartrate) manufactured by Purdue Pharma. Hysingla ER® is indicated in the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Hysingla ER® was developed as an abuse deterrent formulation meaning that the tablet will be difficult to crush, break, or dissolve thereby rendering the medication useless if tampered with.

Hysingla ER will come with a REMS (Risk Evaluation and Mitigation Strategy) associated with it. This medication will be available in seven different strengths ranging from 20mg up to 120mg with a labeled once daily dosing.

As was discussed with the approval of Targiniq ER® and Embeda® it will only be a matter of time until all of these medications begin to appear on claims payment forms.

With approximately 30,000 deaths annually attributed to opioids and the re-classification of Hydrocodone to CII status which took effect last month, will abuse deterrent formulations become the norm or are we just a little too late in combating this epidemic on opioid abuse?

More information can be found on both the Purdue Pharma and FDA websites:

http://www.purduepharma.com/news-media/2014/11/purdue-pharma-l-p-receives-fda-approval-for-hysinglatm-er-hydrocodone-bitartrate-extended-release-tablets-cii-a-once-daily-opioid-analgesic-formulated-with-abuse-deterrent-properties/

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm423977.htm

References:

  1. Facts and Comparisons Online. Clinical Drug Information. 2014.
  2. FDA.gov.
  3. Hysingla ER® Product Information. Purdue Pharma. 2014.

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