FDA Turns Down Abuse-Deterrent Remoxy ER for Pain

Deborah Brauser

August 06, 2018

The US Food and Drug Administration (FDA) today nixed approval of abuse-deterrent (AD) oxycodone extended-release capsules (Remoxy ER, Pain Therapeutics) for the treatment of severe pain, according to a press release from the manufacturer.

The company reported receiving a complete response letter from the FDA stating that the data submitted in the New Drug Application "do not support the conclusion that the benefits…outweigh the risks."

"This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction," Pain Therapeutics' president and CEO Remi Barbier said in the release.

Still, today's decision matched recommendations that came out of an FDA Advisory Committee meeting held in June. As reported by Medscape Medical News, the Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees jointly voted 14 to 3 against recommending approval of the AD drug.

At the time, panel member John B. Hertig, PharmD, Center for Medication Safety Advancement at the College of Pharmacy, Purdue University, Indianapolis, Indiana, said that he applauded the sponsor for being innovative.

However, "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.

"Ideological" Judgment?

According to a briefing document submitted before the June panel meeting, the product would have been used as "an analgesic with properties that can be expected to meaningfully deter the injection, snorting, and smoking routes of abuse." No claim was made regarding deterrence of oral abuse.

Although an FDA presenter at the meeting reported that AD labeling standards were met via the intranasal route because of its high-viscosity gel formulation, panel members were concerned about the FDA's lab showing that material could still be extracted and used via the intravenous route. The members were also concerned about the potential for oral abuse.

However, the manufacturer is fighting back, at least in words, after today's thumbs-down decision from the agency.

"We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence vs OxyContin," said Barbier.

"We relied on the criteria of a fair, neutral, and impartial regulatory review, as any sponsor would. Instead, I believe Remoxy received an ideological judgment call that is vague in nature but conclusive in damaging effects," he said.

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