FDA Withholds Approval of Abuse-Deterrent Opioid

The U.S. Food and Drug Administration has declined to approve an extended-release opioid product called Rexista, developed by Intellipharmaceutics International Inc. The FDA asked the Toronto-based company to complete additional studies to assess the abuse-deterrent properties of its oxycodone tablet. The FDA also asked for more information on a blue dye included in the formulation. The blue dye and a nasal irritant contained in the tablets are intended to deter abuse of the drug. Intellipharmaceutics has been given one year to respond to the agency's requests and can ask for more ...