Rexista Loses Approval Recommendation

US Food and Drug Administration (FDA) advisory committees have voted 22 to 1 against the approval of oxycodone hydrochloride (Rexista), an opioid painkiller designed to be an abuse-deterrent bioequivalent to OxyContin.

The two advisory committees — the Anesthetic and Analgesic Drug Products Advisory Committee and the Risk Management Advisory Committee – also voted 19 to 4 that the drug’s manufacturer, Toronto-based Intellipharmaceutics, did not demonstrate that Rexista has properties that can be expected to deter intravenous abuse.

Finally, the committees unanimously decided that there was not sufficient data to support including language on the drug’s labeling that describes Rexista as being able to deter intravenous abuse.

During the joint meeting, committee members said they would need to review additional safety and efficacy data that could only be obtained through trials on human abuse potential for the oral and intranasal routes of abuse.

Intellipharmaceutics said it intends to honor that request by following an FDA approved protocol.

“[Our} company intends to conduct Category 3 abuse potential studies to provide the data the Company believes necessary to support abuse-deterrent properties of Rexista for the oral and intranasal routes, which are required for abuse-deterrent labeling claims for such routes,” an Intellipharmaceutics statement read.

The study is expected to begin “in the coming weeks,” according to the statement.

Intellipharmaceutics CEO Dr Isa Odidi said she was disappointed with the joint committee results.

“We will endeavor to remedy the concerns raised by completing the necessary human abuse potential studies in relation to the intranasal and oral routes of abuse. We will continue to work with the FDA in progressing this file over the next few weeks as we approach the September 25, 2017 PDUFA date,” Odidi said.

The FDA is not bound by the joint advisory committees’ decision; however, they have usually followed advisory committee recommendations in the past. The agency set a Prescription Drug User Fee Act (PDUFA) goal date of September 25, 2017, for completion of its review of Rexista’s New Drug Application (NDA).