FDA panel rejects Pain Therapeutics’ abuse-deterrent opioid Remoxy

FDA
Pain Therapeutics has received multiple complete response letters for Remoxy. (FDA)

Pain Therapeutics can’t seem to catch a break. On Tuesday, an FDA panel voted against the approval of Remoxy ER, its extended-release, capsule gel form of the opioid oxycodone.

The Austin, Texas-based company licensed Remoxy ER from Durect back in 2002. It is designed to manage pain severe enough to require “daily, around-the-clock, long-term opioid treatment” that isn’t adequately controlled with other options. And its “thick, sticky, high viscosity, hydrophobic” gel formulation is meant to prevent abuse—it’s designed to stop would-be abusers from dividing it into smaller pieces for snorting, or dissolving it for injection.

The advisory committee voted 14-3 against the approval of Remoxy ER. While panel votes are not binding, the FDA usually follows committee recommendations. And this setback is just the latest for the troubled opioid.

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Pain Therapeutics filed its first NDA for Remoxy in June 2008, receiving its first complete response letter from the FDA in December the same year. A few months later, Pain Therapeutics inked a deal around the asset with King Pharmaceutical, which filed a resubmission in December 2010. Pfizer ended up with Remoxy the following February, when it closed its acquisition of King Pharma.

RELATED: Pfizer finally abandons all hope in Remoxy, and Durect/Pain Therapeutics feel the sting

The FDA rejected Remoxy a second time in June 2011—at the time, Pfizer said it would work to fix the issues highlighted in the CRL. But it ended up abandoning ship in 2014, handing the rights to Remoxy back to Pain Therapeutics. The FDA sent yet another CRL for Remoxy in 2016, saying the “NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.”

RELATED: FDA spurs development of devices to combat opioid crisis

At the time, the company said in a statement that the CRL’s focus was abuse deterrence and proposed drug labeling. It made “no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter.”

Pain Therapeutics was down 71% in afterhours trading. The FDA is expected to make a decision by Aug. 7.

The vote comes as the need for non-opioid painkillers is greater than ever. Companies and research institutions alike are racing to get alternatives to market—new approaches include a heroin “vaccine” designed to block the euphoric effects of opioids in the brain and long-acting anesthetics that reduce pain intensity and keep patients off opioids for the first days after surgery.

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