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U.S. Department of Health and Human Services

Drugs

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OxyContin - Questions and Answers

(4/5/2010)

The U.S. Food and Drug Administration has approved a new formulation of the controlled-release drug OxyContin. This new formulation is designed to decrease the likelihood that this medication will be misused or abused, and result in overdose.The new formulation adds in new tamper-resistant features aimed at preserving the controlled release of the active ingredient, oxycodone.

The following question and answers provide some additional background information on OxyContin, the misuse and abuse of this drug, and the significance of this new technology.

What is OxyContin?

How is OxyContin used to treat pain?

Why is OxyContin abused?

What does the new formulation of OxyContin accomplish? Does it decrease the likelihood that this drug will be misused and abused?

How will FDA know if the new version of OxyContin is more resistant to drug misuse and abuse?

 

What is OxyContin?

OxyContin is a prescription narcotic pain reliever that was approved by FDA in 1995. It is manufactured by Purdue Pharma LP, and its active ingredient is oxycodone, a derivative of opium.

How is OxyContin used to treat pain?

OxyContin is made to slowly release the potent opioid oxycodone to treat patients who require around-the-clock medical management with an opioid analgesic for their moderate to severe pain. Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often—a distinct benefit for patients who are in chronic pain.

Why is OxyContin abused?

The primary reason OxyContin is abused is that this drug, like all opioid narcotics, can produce euphoria (a sense of well-being). Euphoria is the primary reason why people use opioids non-medicinally. Chronic non-medicinal use of euphoric-producing drugs can lead to addiction and dependence.

The wide availability of OxyContin, is secondary reason why this drug is popular to use non-medicinally. Although an individual would need a prescription to legally purchase and use OxyContin medicinally, this drug can be easily obtained through illicit channels. The high volume of OxyContin supply available to the public, and the discrepancy between the fair and black market value of the medicine, contributes to diversion, illicit sale, and abuse of OxyContin.

The rates of OxyContin misuse and abuse remain high—in 2008, the number of new nonmedical users of OxyContin aged 12 or older was approximately half a million.1

What does the new formulation of OxyContin accomplish? Does it decrease the likelihood that this drug will be misused and abused?

Over time, individuals have learned effective ways to tamper with OxyContin's controlled-release technology. Tampering with the tablet, via cutting, chewing, breaking, or dissolving, can be very dangerous because it releases high levels of oxycodone all at once.

There have been reports of inadvertent overdose with OxyContin after health care practitioners crushed the drug in order to administer it to patients who could not swallow the tablet.

Tampering with tablets is also popular among individuals seeking OxyContin's euphoric properties. By crushing and snorting, or dissolving and injecting, individuals received a much higher and immediate dose of oxycodone than they would if they swallowed the tablet whole.

The reformulated version of OxyContin is intended to prevent immediate access to the full dose of oxycodone via cutting, chewing, or breaking the tablet. Attempts to dissolve the tablets in liquid result in a gummy substance that cannot be drawn up into a syringe or injected. The new formulation of OxyContin reduces the likelihood that this drug will be misused and abused, although it can not completely eliminate this possibility.

The new formulation can still be abused or misused and result in overdose simply by ingesting or administering it in higher than recommended doses. Health care professionals need to remind their patients of the risks associated with using OxyContin not-as-directed.

How will FDA know if the new version of OxyContin is more resistant to drug misuse and abuse?

FDA is requiring Purdue Pharma LP to conduct a post-marketing study to determine the impact of the new formulation on the use and misuse of OxyContin. Additionally, FDA is requiring the manufacturers to follow a Risk Evaluation and Mitigation Strategy (REMS) for this product, which will include the issuance of a Medication Guide to all patients who will use this product and a requirement for prescriber education on the appropriate use of opioid analgesics in the treatment of pain.

References

1. Substance Abuse and Mental Health Services Administration. (2009). Results from the 2008 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series H-36, HHS Publication No. SMA 09-4434) Rockville, MD.