Cadence Pharmaceuticals’ Pain Reliever Handed Second Regulatory Setback
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the possibility of liver damage. In fact, the acetaminophen–the active ingredient in Tylenol and other over-the-counter pain relievers–is the leading cause of acute liver failure in the U.S.
An FDA advisory committee in June 2009 recommended that the agency take action to mitigate the risk of liver toxicity associated with the use of over-the-counter acetaminophen. Those recommendations included reducing the maximum nonprescription dose from 1000 milligrams to 650 milligrams; switching the 1000 milligram dose to prescription status; and eliminating prescription combinations containing acetaminophen and an opioid drug. The FDA hasn’t taken any action on those recommendations as yet. Cadence has said it believes its drug will be approved despite safety concerns about OTC and combination products.
Cadence also said today that the FDA accepted the name Ofirmev for the drug. The company had intended to market the drug under a different name, Acetavance.
Cadence CEO Ted Schroeder continued to sound positive about the drug’s future. “Cadence is committed to making this important new medicine available to patients and will continue to work closely with the FDA and our third party manufacturer to ensure that the observations are addressed as quickly as possible,” he said in a statement.