Privately-held Tremeau Pharmaceuticals is moving its generic version of Vioxx into Phase III trials for the treatment of hemophilic arthropathy, a degenerative joint disease occurring in patients with hemophilia.
Privately-held Tremeau Pharmaceuticals is moving its generic version of Vioxx into Phase III trials for the treatment of hemophilic arthropathy, a degenerative joint disease occurring in patients with hemophilia.
The current standard of care for hemophilic arthropathy is massive amounts of opioid-based pain killers. But Tremeau believes that its version of Vioxx (rofecoxib), a highly potent cyclooxygenase-2 (COX-2) selective NSAID (nonsteroidal anti-inflammatory drugs), could be the answer for hemophilia patients. But the name Vioxx comes with some baggage.
In 2004, Merck was also forced to pull its arthritis relief Vioxx off the market due to an increased risk of heart attack or stroke. In its first year, Vioxx brought in more than $1.4 billion. But the health risks caused a reversal of fortune for that medication and its revenue stream. Merck also faced numerous lawsuits regarding Vioxx and those health risks.
Vioxx isn’t new as a treatment for hemophilia patients. Stat News noted that prior to Vioxx’s recall, it was “the off-label drug of choice to treat hemophilic arthropathy,” which is caused by recurrent intra-articular bleeding. Hemophilic arthropathy is the largest cause of morbidity in patients with hemophilia. Currently, there are no approved treatments for this disease.
When Vioxx was pulled from the shelves, Dr. Ellis Neufeld, clinical director of hematology at St. Jude Children’s Research Hospital in Memphis, told Stat that decision robbed hemophilia patients of an important treatment.
And that’s one reason Tremeau wants to bring Vioxx through the clinic and restore this treatment for hemophilia patients. Despite the issues that caused Merck to pull Vioxx from the shelves, Tremeau believes that the multiple scientific evaluations conducted over the last 10 years showed that Vioxx still had potential in treating patients. This time though, for hemophilic arthropathy, as well as other potential indications in which a COX-2 selective NSAID may provide therapeutic advantages over other standards of care, such as opioids. In its own clinical tests, Tremeau has shown that rofecoxib has no effect on bleeding time relative to placebo. And that’s a solid point in favor of Vioxx for this indication. Use of NSAIDs are typically avoided in hemophilia patients due to their effects on platelet aggregation and risk of gastrointestinal ulcers, Tremeau said. That makes opioids the standard of care for these patients, however, as the world has witnessed, there are significant problems associated with prolonged opioid use. Unlike opioids, Vioxx, or TRM-201 as Tremeau calls it, is a non-narcotic analgesic.
In 2017, the U.S. Food and Drug Administration awarded TRM-201 Orphan Drug designation for the treatment of hemophilic arthropathy. Last year, the company raised $5.2 million from its investors to advance TRM-201’s development. That $5.2 million was the company’s first equity round.
According to the U.S. Centers for Disease Control and Prevention, there are an estimated 20,000 cases of hemophilia in the United States.
