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Rexista, Generic Oxycodone, Fails Hurdle Toward Approval

July 27, 2017
The safety committees noted safety concerns regarding the extended-release tablets ability to prevent abuse or misuse as a reason not to recommend approval of the NDA.

In a vote of 22 to 1, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA found that Intellipharmaceutics International Inc's New Drug Application for Rexista (extended-release abuse-deterrent oxycodone hydrochloride) should not be approved at this time.

Citing safety concerns about the ability of the product to deter abuse, the committees also voted against abuse-deterrent labelling. The company "has not demonstrated that Rexista has properties that can be expected to deter abuse by the intravenous route of administration." The committees also voted 23 to 0 that there "are not sufficient data for Rexista to support inclusion of language regarding abuse-deterrent properties in the product label for the intravenous route of administration," noted a press release from the company.1

However, the committees expressed a desire to review the additional safety and efficacy data for Rexista that may be obtained from human abuse potential studies for the oral and intranasal routes of administration, which the company plans to commence in the next few weeks. 

Rexista is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Although the FDA is not bound by the advisory committees' recommendation, they usually follow their recommendations.

According to the agency, the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of September 25, 2017 for completion of its review Rexista NDA candidate. The CEO of Intellipharmaceutics, Dr. Isa Odidi, said, "While we are disappointed with the Committees' overall vote, 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."


Last updated on: November 5, 2020
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