FDA approves new opioid painkiller said to last 24 hours

Federal regulators gave the green light to a once-a-day opioid pain-relief pill that is up to 24 times more powerful than a single Vicodin but is designed to thwart the immediate release of its full – and potentially lethal – payload.

The U.S. Food and Drug Administration’s approval of Hysingla ER, an extended-release form of the widely prescribed hydrocodone, comes amid controversy over the proliferation of powerful narcotic painkillers in the face of an epidemic of addiction and overdose.

The maximum dose of Hysingla packs 120 milligrams of hydrocodone, the opioid analgesic contained in Vicodin, which is sold in 5- to 10-milligram doses. But when taken as directed, the new pill releases its medicine over 24 hours.

Hysingla is intended to be swallowed whole. The FDA expects it to reduce – but not totally prevent – people’s ability to abuse it by chewing it or smashing it into a powder that they snort or inject. The tablet forms a thick gel if it is crushed, making it difficult to inject.

But, the agency and the manufacturer acknowledged that abuse is still possible, and an overdose can result in death.

The approval of Hysingla is part of the FDA’s response to mounting overdose deaths involving prescription painkillers. The agency is encouraging drugmakers to make narcotic painkillers safer by developing abuse-deterrent formulations.

Hysingla’s only active ingredient is hydrocodone. Other forms of hydrocodone, such as Vicodin and Norco, also contain acetaminophen, which carries the risk of liver toxicity, the FDA noted in its review.

Mark Timney, chief executive of Purdue Pharma, said his company was proud to bring patients another pain treatment option. Hysingla is the company’s third approved abuse-deterrent opioid. The active ingredient in the others is oxycodone, a close cousin of hydrocodone.

Hysingla comes a little more than a year after the FDA approved Zohydro ER, another long-acting form of hydrocodone. Designed to last 12 hours, Zohydro is available in strengths of up to 50 milligrams – 10 times the lowest dose of Vicodin. Because Zohydro can easily be crushed, its approval prompted criticism from addiction experts and public health officials who feared it would quickly become abused.

Dr. Andrew Kolodny, an addiction expert, said he feared that it was just a matter of time before addicts figure out how to abuse Hysingla.

“I think it’s an extremely dangerous product,” said Kolodny, who helped found Physicians for Responsible Opioid Prescribing. “A pill that’s so strong makes me very concerned that this product may be more dangerous than Zohydro.”