Many Americans dealing with pain will soon have a new option when it comes to managing it. The U.S. Food and Drug Administration approved a new immediate-release tablet for the management of moderate to severe pain.
As with Other Opiates, New Drug has Potential for Abuse
Tapentadol is manufactured by Janssen Ortho, LLC, in Gurabo, PR., a subsidiary of Johnson & Johnson. It will be available once the U.S. Drug Enforcement Agency classifies the controlled substance in its drug schedule. The FDA says opiates are “safe and effective in selected patients but can cause dependence, abuse and addiction.” Approval was based on clinical studies of more than 2,100 patients presented earlier this year at the annual scientific meeting of the American Pain Society. The studies found Tapentadol to provide significant relief when compared to a placebo. A trade name for Tapentadol has not yet been established.