The Food and Drug Administration on Monday declined to approve Intellipharmaceutics International's long-acting opioid painkiller, Oxycodone ER, reports Reuters.
Oxycodone ER releases a blue dye and nasal irritant when manipulated to help identify illicit users and discourage misuse of the drug. Intellipharma designed the drug as an abuse-deterrent version of Purdue Pharma's opioid, OcyContin.
The FDA rejected OxyCodone ER in its current form and requested additional proof of the drug's abuse-deterrent qualities, as well as more information on the drug's blue dye. An FDA advisory panel in July voted 22-1 against approving the drug, with some experts expressing concerns about the dye's possible toxicity.
Intellipharma has at least one year to provide the FDA with the requested information. The drugmaker said the regulatory decision will not affect Oxycodone ER's marketing timeline, according to Reuters.
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