Remoxy ER is a thick, sticky, high-viscosity capsule formulation designed to deter abuse via injection, snorting and smoking.
The US Food and Drug Administration (FDA) has accepted Pain Therapeutics, Inc’s New Drug Application (NDA) for extended-release oxycodone (CII) capsules (Remoxy ER), a twice daily prescription therapy for severe chronic pain that the company says carries abuse-deterrent properties.
The drug is a “thick, sticky, high-viscosity capsule formulation designed to deter unapproved routes of drug administration, such as injection, snorting or smoking,” Pain Therapeutics wrote in a statement. It was specifically developed to curb oxycodone abuse, while continuing to provide 12 hours of steady pain relief when used appropriately.
A Prescription Drug User Fee Act (PDUFA) action date has been set for August 7, 2018. Pain Therapeutics said they expect the FDA to hold an open advisory committee meeting to discuss the drug’s safety, efficacy and abuse-deterrent potential prior to announcing a decision.
Except for a 2014 study suggesting that the 2010 approval of OxyContin—the first approved abuse-deterrent opioid—marked a decline in its use “after accounting for the simultaneous contraction of the generic extended-release oxycodone market,” there is not much evidence to suggest that abuse-deterrent opioids have helped curb abuse. Another study from 2015 found that abuse-deterrent formulations for opioids can curtail abuse, but “the extent of their effectiveness has clear limits,” authors wrote, often resulting in significant levels of residual abuse.
In the 2014 study’s conclusion, the authors said that further scrutiny into abuse-deterrent formulations (AEFs) is “vital, given their popularity in opioid drug development.” Indeed, scarce evidence has not scared pharma manufacturers from racing to bring abuse-deterrent opioids to market. There are currently about 10 AEFs commercially available, and Pain Therapeutics has 2 more in the pipeline—Remoxy ER and a transdermal fentanyl patch system (Fenrock), an abuse-deterrent skin patch for severe pain whose research was funded by the National Institute on Drug Abuse.
With pressure mounting in the middle of a nationwide epidemic, even FDA commissioner Scott Gottlieb, MD, who has held fast to scientific evidence and data as the guiding light of his administration’s decision making, seems to be relying more on the advice of advisory committees than peer-reviewed data—perhaps because there’s just not enough of it.
Gottlieb announced last summer that the agency would study pharma’s trend toward developing abuse-deterrent opioids to determine if “we have the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic.”
In late July, the agency scheduled a joint advisory committee meeting to weigh the risk-benefit profile of Intellipharmaceutics Corp.’s oxycodone hydrochloride (Rexista). The committees voted 22 to 1 against its approval, and unanimously agreed that there was not sufficient data to support including language on the drug’s labeling saying that it could deter abuse intravenously. Rexista’s NDA was subsequently rejected by the FDA in September.
“One thing is clear,” Gottlieb wrote. “we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations; and I look forward to a productive discussion on how to best tackle this challenge.”
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