FDA challenges abuse-deterrent opioid drug claim

The FDA is pushing back on an abuse-deterrent claim by an opioid drug candidate.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Committee wants to review additional safety and efficacy data for abuse-deterrent oxycodone hydrochloride extended-release (ER) tablets (Rexista). 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.

This decision is not that surprising, says James Boiani, a member of the firm Epstein Becker Green’s Washington, D.C., office.

Boiani

“In July of this year, the FDA presented the Rexista application to FDA advisory committees which concluded by a wide margin that abuse deterrence claims made in the application had not been proven,” Boiani says. “More broadly, though, what is happening is that the FDA and committee members are strictly scrutinizing claims about abuse deterrence in response to the opioid crisis and, I think, lingering concerns that the addictiveness of previously approved opioids was not adequately communicated to physicians or patients. No one wants a product coming out with implied promises of preventing abuse that gives a bump to opioid prescribing without knowing with certainty that it will actually help deter abuse.”

The manufacturer, Intellipharmaceutics, will “continue to work closely with the FDA to provide them with the additional information they requested, including data supporting the label claims related to oxycodone ER’s abuse-deterrent properties,” according to a press release.

Problems, alternative solutions

“If you’re in managed care, abuse deterrence related to use of opioids continues to be a major problem,” Boiani says. “Although opioids can be very effective in managing pain, it is critically important to continue the search for alternatives.”

Alternative pain management may not essentially involve drugs, but medical devices, says Boiani. “There has been a growing interest in pain management medical devices which are inherently non-narcotic,” he says. “It is important to keep these in mind.

“I also think that the decision should provide more assurance to managed care executives that when an FDA-approved claim about abuse deterrence is made it will have been run through its paces before making it onto a drug label, so you can have confidence in the claim,” he says.

“The epidemic was caused in part by not appreciating the truly addictive nature of these products,” says Boiani. “Allowing a new product on the market with promises of being safer could encourage increased use of opioids at a time that the FDA is acutely aware of their dangers. If the benefits are well validated in terms of abuse deterrence, everyone would be in favor of getting the product to the market quickly. If there are any outstanding questions about that benefit, though, the FDA will put the brakes on approval.”