FDA Approves Hard-to-Abuse 24-Hour Painkiller
The U.S. Food and Drug Administration (FDA) has approved a new powerful painkiller that will be a lot harder to crush, break or dissolve, making it more difficult to abuse.
"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 reported by the Washington Post. "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."
The drug, Hysingla ER, contains a pure dose of hydrocodone and is categorized as an opioid. Opioids are effective drugs for treating pain but have been frequently abused, causing about 15,000 deaths per year. Hysingla ER, manufactured by Purdue Pharma, will be the first ever drug-deterrent version of Zohydro ER, which was approved by the agency last fall. The opioid is an extended-release acting drug that can treat pain for up to 24 hours.
"For patients who benefit from hydrocodone alone for the treatment of pain severe enough to need an opioid, this offers the advantage of once-a-day dosing in a formulation that we expect will reduce abuse and misuse," said Dr. Douglas Throckmorton, deputy center director for regulatory programs at the F.D.A, reported by the New York Times.
Hysingla ER does not include acetaminophen, which has been linked to liver damage. Other prescription painkillers, such as Vicodin, contain hydrocodone and acetaminophen. Hysingla ER will be too hard to crush easily and will turn into a gooey substance when placed in water, making it difficult for abusers to take the drug with a syringe.
"These innovations are an important step forward in helping meet patients' needs while also working to deter misuse and abuse," Mark Timney, chief executive of Purdue Pharma, added.
Even though Hysingla ER is considered drug-deterrent, many experts are still concerned about its potential danger. Just one tablet can have as much as 120 milligrams of hydrocodone. Some experts believe that down the line, people will be able to find an easy way to abuse the drug.