FDA Panels Nix Approval of Abuse-Deterrent Oxycodone for Pain

Deborah Brauser

June 27, 2018

Two US Food and Drug Administration (FDA) panels voted overwhelmingly against recommending approval of abuse-deterrent (AD) oxycodone extended-release capsules (Remoxy ER, Pain Therapeutics) for severe pain.

Together, the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14-3 that data presented on the efficacy, safety, and risk-benefit profile of the product did not support the approval of its application — especially when it came to the specific AD claims.

"I voted no because I think, ultimately, we need to do better for our patients both with chronic pain and those who struggle with abuse," said panel member John B. Hertig, PharmD, associate director at the Center for Medication Safety Advancement at the College of Pharmacy, Purdue University, Indianapolis, Indiana.

"I applaud the sponsor for being innovative and taking a step in the right direction but ultimately, when I'm balancing the risk-benefit and the availability of some similar options that are currently on the market compared with the possible public health impact, for me it was a no," said Hertig.

Approval was sought for the product "as an analgesic with properties that can be expected to meaningfully deter the injection, snorting, and smoking routes of abuse," according to a briefing document from the manufacturer. Interestingly, "sponsor does not seek a label claim for oral abuse," the company added.

The twice-daily ER product has a high-viscosity gel formulation designed to keep abusers from being able to "cut, grate, or divide" it, while also resisting "syringeability, injection, and rapid extraction" and sticking to tools or equipment used for abuse.

However, an FDA presenter at the meeting noted that while data met current standards for AD labelling via the intranasal route, the agency's lab showed that "oxycodone suitable for IV [intravenous] use" could be extracted from the product under certain conditions.

"It's Complicated"

Although the manufacturer wasn't looking for a claim about oral abuse, the panel members felt it still needed to be discussed.

Of those who gave specifics during the official discussion periods, six of six said that oral deterrence was not shown in the submitted data, five of six said that nasal deterrence was shown, and three of six expressed concerns over the IV deterrence data.

They also mostly said yes, no, and "it's complicated" for product labeling stating support for AD effects for nasal, oral, and IV routes of abuse, respectively.

Concern over the AD data was the top reason cited for today's "no" votes regarding overall approval recommendation, although other issues were brought up, including public safety concerns and that there could be another situation "reminiscent of Opana." With that drug, nasal deterrence led to an increase in IV abuse.

"You don't help patients with bad solutions," said Raeford E. Brown Jr, MD, professor of anesthesiology and pediatrics at the College of Medicine at the University of Kentucky, Lexington.

"I voted no because the risk of oral and IV misuse and abuse, as well as the risk of creating a false sense of safety, outweighed the benefits of possible nasal deterrence and the benefits to patients for pain management," patient representative Jennifer M. Spotila, JD, Philadelphia, Pennsylvania, commented.

Thomas E. Prisinzano, PhD, professor in the Department of Medicinal Chemistry at the University of Kansas School of Pharmacy, Lawrence, was one of the three "yes" votes.

"I felt that the company did meet the criteria for abuse deterrence in terms of intravenous and intranasal. And oral is always going to be a problem in this particular case," he said. "We're in desperate need for things for chronic pain and I felt that the data showed it was effective in chronic pain."

The Prescription Drug User Fee Act target date for an approval decision by the FDA is scheduled for August 7.

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