Magazine article Clinical Psychiatry News

Abuse-Deterring OxyContin Gets Nod from Agency

Magazine article Clinical Psychiatry News

Abuse-Deterring OxyContin Gets Nod from Agency

Article excerpt

In an 11th-hour action that derailed the possibility of generic formulations of controlled-release oxycodone (OxyContin) from appearing on the U.S. market anytime soon, the Food and Drug Administration announced that it withdrew its approval of the original, conventional formulation of OxyContin.

Acting on the very day that the patent on the original formulation of OxyContin, held by Purdue Pharma, was set to expire, the FDA took an additional step to support the newer formulation of OxyContin that Purdue has marketed exclusively since August 2010. The newer version includes a polymer so that, when a pill is crushed and then mixed with water it turns into a gel rather than remaining a more easily manipulated powder. The FDA approved updated labeling for OxyContin that highlights the abuse-deterring features of the newer formulation, which means that Purdue can now cite these attributes when marketing the drug.

The FDA "approved labeling for reformulated OxyContin stating that it possesses physiochemical properties that are expected to: (1) make abuse via injection difficult, and (2) reduce abuse via the intranasal route. This is the first opioid product for which FDA has approved labeling that includes statements regarding abuse-deterrence," according to a letter from FDA Commissioner Margaret A. …

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