Updated: Jul 23
Tremeau Pharmaceuticals, a private Massachusetts company, is developing a generic version of Vioxx as a treatment for severe joint pain in people with hemophilia. The company plans to begin a pivotal trial next year and, if the resulting data are positive, Tremeau will apply for FDA approval in hopes of bringing Vioxx back to market more than 15 years after Merck pulled it from shelves.
Vioxx’s days as a widely used treatment for arthritis and chronic pain came to an end when studies revealed that it roughly doubled patients’ risk of heart attack and stroke, leading to an estimated 60,000 deaths. It was a public health disaster, and it led to a congressional investigation, allegations of lapses at the Food and Drug Administration, and agreement by the manufacturer, Merck, to pay a nearly $5 billion settlement.