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Intellipharmaceutics to conduct new HAP study to support abuse-deterrent claim for Rexista

  • In a statement issued after yesterday's negative Ad Com vote on oxycodone candidate Rexista, Intellipharmaceutics (OTC:IPCI) says it will conduct a new human abuse potential (HAP) study to support an abuse-deterrent claim for the oral and intranasal routes. It plans to initiate the study in the coming weeks.
  • More data will be required to support an abuse-deterrent claim for the intravenous route as well, but the company does not disclose its plans for addressing this.
  • The FDA's action date is September 25.
  • Previously: FDA Ad Com thumbs down on Intellipharmaceutics' oxycodone (July 26)

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Intellipharmaceutics International Inc.