The Food and Drug Administration, which last year faced widespread criticism when it approved a powerful painkiller that critics said would be easy to misuse, on Thursday approved a new form of the drug that will be hard to crush, break or dissolve -- common tactics for people trying to ingest large amounts quickly by snorting or injecting the drug.
Hysingla ER, like its controversial predecessor Zohydro ER, is composed of a dose of pure hydrocodone, the main ingredient in the painkiller Vicodin. The FDA noted Thursday that its deterrence features are "expected to reduce, but not totally prevent" abuse of the drug.
"Currently available abuse-deterrent technologies are important and offer a step in the right direction, but the science in this area is still evolving," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, wrote in a post on the agency's website. "Prescription opioids with abuse-deterrent properties will not completely fix the prescription opioid abuse problem, but they can be part of a comprehensive approach to combat the epidemic."
Along with medications such as oxycodone and morphine, Hysingla is part of a group of drugs known as opioids, which are effective at relieving serious pain but also have played a central role in the nation's epidemic of deaths linked to painkiller addiction. Roughly 15,000 people die each year from overdoses involving prescription painkillers, according to the Centers for Disease Control and Prevention.
Hysingla, an extended-release drug produced by industry giant Purdue Pharma, is the first abuse-deterrent alternative to Zohydro ER, which is made by California drug maker Zogenix. The FDA approved Zohydro last fall against the recommendation of its own advisory committee, and in the face of opposition from lawmakers, addiction experts and law enforcement officials around the country.
Massachusetts Gov. Deval Patrick tried to ban Zohydro when it hit the market in March, declaring a public health emergency and saying the drug could deepen the state's prescription abuse epidemic. But a judge ruled that the state could not overrule the judgment of the FDA, and effectively revoked the ban.
Hysingla ER's pure hydrocodone formulation, like Zohydro's, is intended to allow for the long-term treatment of chronic pain without posing the risk of liver damage that comes with additional ingredients such as acetaminophen. In a statement Thursday, Purdue said the new drug will be an important tool in dealing with the chronic pain suffered by millions of Americans.
“These innovations are an important step forward in helping meet patients’ needs while also working to deter misuse and abuse," said Mark Timney, chief executive of the company, which also makes an abuse-deterrent form of the opioid OxyContin.
Not everyone was so upbeat.
"I'm very disturbed," said Andrew Kolodny, an addiction doctor and president of Physicians for Responsible Opioid Prescribing. "I’m concerned about the product. I believe it may be more dangerous than Zohydro."
Kolodny said that because Hysingla is intended to work over 24 hours, it comes in doses as high as 120 milligrams. Zohydro, which is intended to be taken every 12 hours, has a maximum dose of 50 mg. Because the abuse deterrence technologies aren't infallible, he said, that means Hysingla could actually pose the bigger risk. The FDA said the range of tablet strengths for Hysingla is "comparable to existing approved [extended-release] products."
Kolodny also criticized the agency for not holding an advisory committee meeting before approving the new drug, especially given the intense public interest in the issue. He said he fears that yet another opioid on the market will lead to another push by the industry to market the drug and push doctors to write more prescriptions.
"That’s not what we need in the midst of an epidemic caused by over-prescribing of painkillers," he said. "If the prescribing continues to go up, so will the overdoses, death and addiction."