Hydrocodone Bitartrate extended release: A new therapeutic agent for the management of Chronic Pain.

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Hydrocodone Bitartrate extended release: A new therapeutic agent for the management of Chronic Pain.

Hydrocodone bitartrate is often prescribed in combination with acetaminophen (which is believed to increase the effect of the hydrocodone) to relieve the moderate to severe pain. It is also prescribed in the treatment of cough. However, hydrocodone bitartrate extended release (ER) was the first single entity hydrocodone formulation recognized by the USFDA as having abuse-deterrent properties.

Hydrocodone bitartrate  is indicated for the management of severe pain that requires daily, around the clock, long term opioid treatment and for which alternative treatment options are inadequate. Once daily oral hydrocodone ER provides consistent plasma hydrocodone concentration and sustained analgesia over the 24 hour dosing interval. Its physiochemical properties render hydrocodone ER harder to manipulate physically which is expected to deter intranasal, intravenous and oral abuse.

A clinical study showed significantly reduced drug liking which was relative to the hydrocodone solution. In   two large phase III studies including patients with chronic pain, hydrocodone ER reduced pain intensity and then maintained during the treatment. During maintenance therapy, most patients continued hydrocodone ER at the dosage achieved at the end of dose titration and did not require increased doses of supplemental pain medication suggesting the adequate pain management.

Analysis showed that hydrocodone ER was generally well tolerated, with a safety profile consistent with other μ-opioid analgesics. However, like other opioids, it was also associated with the risks of addiction, abuse/misuse and serious adverse events, such as respiratory depression, withdrawal, physical dependence and overdose. Although large post marketing studies are should be undertaken to determine whether the abuse-deterrent properties of hydrocodone ER resulting in meaningful reductions in abuse, misuse and related adverse clinical outcomes. Evidences from the current study indicates that hydrocodone ER is a useful treatment option for patients with chronic pain.


Clin Drug Investig. 2016 Oct 7.


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Original title of article:

Hydrocodone Bitartrate ER (Hysingla® ER): A Review in Chronic Pain


Sohita Dhillon

Clin Drug Investig. 2016 Oct 7.
Therapeutic, Hydrocodone bitartrate, Back pain, Lower back, Chronic, Hydrocodone, Review, Efficacy Safety, Oral
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