Controlled-Release OxyContin Approved as Rx ODs Spike - Pharmaceutical Executive

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Controlled-Release OxyContin Approved as Rx ODs Spike



FDA, on Monday, approved a new formulation of the painkiller OxyContin (oxycodone) that’s designed to curtail the abuse typically associated with the opioid.

Manufactured by Purdue Pharma, OxyContin has had a history of misuse, going as far as being dubbed Hillbilly Heroin on the street. The new version builds on the current extended release formulation, and adds fail-safe mechanisms to keep users from crushing the drug in an effort to inject or snort it.

That said, FDA still believes that abusers will be able to get high by just taking a larger quantity of the drug.

“Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction,” stated Bob Rappaport, director of the Division of Anesthesia and Analgesia Products in the FDA’s Center for Drug Evaluation and Research. “As with all opioids, safety is an important consideration,” he said. “Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain.”

In related news, the American Journal of Preventative Medicine released a study, on Tuesday, stating that the number of hospitalizations in the US due to overdoses of opioids and sedatives ballooned 65 percent from 1999 to 2006.

Methadone and benzodiazepine overdoses or poisoning increased 400 and 39 percent, respectively. While hospitalization due to overdose of barbiturates and antidepressants dropped 41 and 13 percent.

“Deaths and hospitalizations associated with prescription drug misuse have reached epidemic proportions,” stated lead author, Jeffrey H. Coben of the West Virginia University School of Medicine. “It is essential that health care providers, pharmacists, insurance providers, state and federal agencies, and the general public all work together to address this crisis. Prescription medications are just as powerful and dangerous as other notorious street drugs, and we need to ensure people are aware of these dangers and that treatment services are available for those with substance abuse problems.”

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