On Thursday, the Food and Drug Administration approved Hysingla, a powerful long-acting opioid painkiller. The drug is an extended-release formulation to be taken once every 24 hours for patients who need round-the-clock pain relief. Hysingla is being marketed as an “abuse-deterrent” drug, meaning that it cannot easily be broken or crushed in order to be snorted or injected.
Dr. Douglas Throckmorton, deputy center director for regulatory programs at the F.D.A, said, “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.”
However, addiction experts caution that the drug has the potential for abuse even if the pills cannot be easily crushed. Phoenix House’s Chief Medical Officer Andrew Kolodny, M.D. said Hysingla tablets are particularly dangerous because they “pack an enormous amount of hydrocodone.” He expressed disappointment that the F.D.A. did not seek review by an advisory committee of experts before approving it for use.
Over the past decade, at least 125,000 deaths in the U.S. have been attributed to opioids, a class of drug that includes prescription painkillers and heroin. The Centers for Disease Control and Prevention has declared the rising rate of opioid overdoses the worst drug epidemic in U.S. history, and cites a parallel 300 percent increase in the sale of painkillers as a major contributor to the crisis. Scientists are attempting to create a non-addictive opioid painkiller, but pain and addiction experts are skeptical, saying they were once told that OxyContin, one of the drugs that fueled the epidemic, was not addictive.
Dr. Kolodny has said in the past that combating the crisis will require curbing opioid prescribing to prevent more people from becoming addicted and expanding access to treatment for people already struggling with addiction.
Source: New York Times –