FDA Rejects Abuse-Deterrent Opioid, Seeks Additional Information

The FDA has rejected an abuse-deterrent opioid citing the need for further evidence. Rexista, an Oxycodone Hydrochloride Extended-Release tablet (Oxycodone ER), was developed by Intellipharmaceutics International Inc as an abuse- and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for pain relief.

The FDA sent a Complete Response Letter to the company requesting more information, as well as that Intellipharmaceutics complete more studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes. The agency is also looking for more information about the blue dye that is intended to deter abuse.

According to Isa Odidi, PhD, MBA, CEO of Intellipharmaceutics, the letter from the FDA was encouraging since it clarifies the path going forward.

"We will continue to work closely with the FDA to provide them with the additional information they requested, including data supporting the label claims related to Oxycodone ER's abuse-deterrent properties,” Odidi said in a statement. “We believe our Oxycodone ER product can play an important preventative role in the midst of a serious opioid abuse crisis particularly impacting North America. The Company will be providing regular updates as we execute on our Oxycodone ER NDA resubmission plan."

The company has 1 year to respond to the letter from the FDA, but can request additional time. In addition, the FDA has asked that Intellipharmaceutics submit an alternative proprietary name for the drug.

In June, the FDA Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 22-1 against approving Intellipharmaceutics’ New Drug Application for Rexista. They also voted 19-4 that Rexista hadn’t been proven to deter abuse by intravenous methods.

Rexista is supposed to be difficult to abuse because when it is crushed or pulverized, the drug coagulates, which makes it difficult to inject or snort. The drug has a blue dye that is emitted once the tablet is tampered with—the expectation was that the blue dye may act as a deterrent because of stigma and serve as an early warning to flag potential misuse or abuse.

At the 30th US Psychiatric and Mental Health Congress Thomas Kosten, MD, a psychiatrist with Baylor College of Medicine, explained that there is evidence that tamper-resistant and abuse-resistant formulations of opioids decrease the abuse of that specific drug, but that payers aren’t as willing to cover these formulations because they cost substantially more.