A panel of independent advisers for the Food and Drug Administration on Wednesday decided there was not enough evidence to support approval for Toronto-based Intellipharmaceutic's long-acting, abuse-deterrent opioid Rexista, according to Reuters.
Here are five things to know.
1. Rexista is a tamper-resistant opioid comparable to Oxycontin. The drug releases a blue dye when it's been manipulated, which could help identify illicit users of the drug and acts as a nasal irritant to prevent drug abuse.
2. Intellipharmaceutics is seeking a drug label stating Rexista reduces the likelihood of intravenous drug abuse.
3. The FDA panel voted 22-1 against approving the drug largely because the pharmaceutical company did not conduct any human trials to provide evidence the drug works as intended. Panelists also cited a lack of data on the drug's abuse-deterrent properties and expressed concerns over the safety of the blue dye.
4. The FDA is not required to follow the advisory panel's recommendation, but usually does so.
5. In June, FDA Commissioner Scott Gottlieb, MD, said the agency would increase scrutiny of abuse-deterrent opioids to determine whether the medications help to mitigate the rising rates of opioid addiction.
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