Published On June 10, 2015
In late 2013, the U.S. Food and Drug Administration approved the drug Zohydro, the first long-acting formulation of the opioid painkiller hydrocodone. The agency contended that the drug was needed and useful, but its decision quickly drew sharp criticism. Zohydro contains up to five times the hydrocodone used in popular short-acting formulations such as Vicodin. The FDA’s own advisory committee recommended against approving the new drug in an 11-2 vote, citing concerns about the drug’s potential for improper use.
“Zohydro doesn’t serve a compelling clinical need,” says G. Caleb Alexander, a physician and co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health. “The overall risk-benefit balance wasn’t such that it should have been approved.” Alexander joined dozens of health care agencies, consumer groups, and state and federal officials—including attorneys general from 28 states—calling for the FDA to reconsider. Last September, 19 patient advocacy groups went even further, demanding the resignation of the FDA’s then-commissioner, Margaret Hamburg.
The firestorm over Zohydro was kindled in a time of epidemic addiction to prescription drugs. More than 12 million Americans use them in ways their doctors did not intend, according to the Centers for Disease Control and Prevention, and more than 400,000 of that population ends up in the emergency room every year. Death rates from overdose of prescription opioids have quadrupled in the United States since 1999.
Yet simply keeping a new drug from the marketplace, the FDA countered, was no way to combat the problem. Zohydro and other painkillers are sorely needed treatments for patients with chronic pain—a population that numbers 100 million, according to an Institute of Medicine report. Zohydro in particular is the first form of hydrocodone without acetaminophen, which has been associated with toxic liver damage for long-term users. In a separate response published in JAMA, several senior FDA officials faulted the strategy of blockading useful drugs.
The agency has stated that it favors addressing prescription abuse through regulatory changes. These include tighter regulations on the oversight, marketing and prescribing of opioid drugs. Zogenix, the maker of Zohydro, is required to conduct new studies on the drug’s risks, to carry more extensive labeling, and to educate physicians and patients about how to safely use and store the drug.
The FDA has also been evolving guidelines for “abuse deterrent” medications that prevent capsules from being crushed or dissolved, making it harder for addicts to snort or inject. A new version of Zohydro was recently approved with similar features. (Critics counter that simply swallowing the whole capsule will still produce a high.)
More recently, in 2014 the FDA reclassified drugs containing hydrocodone from Schedule III to Schedule II, indicating a higher potential for misuse that subjects them to new restrictions for patients, prescribers and pharmacies. “We think this reclassification will have an enormous impact over time to get the opioid epidemic under control,” says Andrew Kolodny, chief medical officer of the Phoenix House addiction treatment center and director of Physicians for Responsible Opioid Prescribing, which was one of many groups that pushed for the change.
Another extended-release opioid painkiller, Purdue Pharma’s Hysingla ER, came on the market this spring. Kolodny and other critics say the new painkiller could pose an even bigger risk, as it comes in dosages as high as 120 milligrams and is intended to work over 24 hours. The FDA’s approval was followed by a note of caution, and agency officials acknowledged that the abuse-deterrent properties of the new drug are expected “to reduce—but not totally prevent—abuse.” While it is clear there are no cure-alls, it remains to be seen if this and other new FDA protections will help reduce the incidence of death and addiction related to the misuse of opioid drugs.
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