Xtampza ER Approved By FDA To Include Oral Abuse-Deterrent Labeling

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Xtampza ER Approved By FDA To Include Oral Abuse-Deterrent Labeling

The Food and Drug Administration recently approved a labeling update for Xtampza ER, an extended-release oxycodone product that is indicated for the treatment of daily, around-the-clock pain that cannot be managed using other treatment options.

The drug has been touted as abuse-deterrent and has been adopted for coverage by some insurance companies in place of OxyContin. Purdue Pharma, the makers of OxyContin, has been the defendant in multiple lawsuits, with cities, states, and municipalities alleging their direct contribution to the opioid epidemic.

The new labeling includes data from two studies that evaluated the effect of crushing Xtampza ER compared to the abuse-deterrent formulation of OxyContin and a control.

Additionally, the label includes data from an oral abuse study that compared intact vs. manipulated Xtampza ER to immediate-release release oxycodone, which yielded lower “Drug Liking and Take Drug Again Visual Analogue Scale” scores with oral use of intact Xtampza vs. use of crushed oxycodone immediate-release.

The label also notes that the drug’s oral abuse-deterrent properties. Michael Heffernan, CEO of Collegium Pharmaceuticals, the makers of Xtampza ER:

“With the addition of comparative pharmacokinetic data with OxyContin and an oral abuse-deterrent claim, Xtampza ER is the only single agent oxycodone with oral, intranasal and intravenous abuse-deterrent labeling.”

The Drug Enforcement Administration categorizes Xtampza ER as a Schedule II controlled substance, and it is available as 9 mg, 13.5 mg, 18 mg, 27 mg, and 36 mg strength extended-release formulations.

According to the Centers for Disease Control and Prevention, 4 out of 5 heroin users state they became addicted to prescription opioids before they first initiated their habit. In 2015, more than 33,000 people in the United States died from overdoses related to prescription painkillers such as OxyContin or illegal opioids such as heroin and fentanyl.

~ G. Nathalee Serrels, M.A., Psychology

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