Rare Daily Staff
Tremeau Pharmaceuticals is seeking to bring Vioxx back to the market as a pain treatment for hemophilic arthropathy, a rare degenerative joint disease in patients with hemophilia, and has won orphan drug designation for it from the U.S. Food and Drug Administration.
Rofecoxib, is a COX-2 selective non-steroidal anti-inflammatory drug. Merck & Co. had developed the drug and marketed the drug under the brand name Vioxx, but withdrew it over concerns that the drug elevated the risk of heart attack and stroke.
“Being granted an orphan drug designation for rofecoxib by FDA is an important regulatory milestone for Tremeau and affirms our strategy of providing non-opioid pain treatments for rare diseases like hemophilic arthropathy,” said Bradford Sippy, CEO of Tremeau. “Combined with our ongoing conversations with FDA of our proposed development plan for rofecoxib, we are well positioned to move forward with the development and introduction of rofecoxib for this specific use.”
Hemophilic arthropathy is caused by recurrent intra-articular bleeding. It is the largest cause of morbidity in patients with hemophilia. There are no medications currently approved or licensed in the United States to treat HA. Because hemophilia patients with hemophilia are at a heightened risk for hemorrhaging events, including gastrointestinal bleeding. Traditional NSAIDs are avoided in this population due to their effects on platelet aggregation and risk of gastrointestinal ulcers, and high potency opioids are the current standard of care in treating HA.
Rofecoxib is seen as well-suited for HA patients because it has no effect on bleeding time relative to placebo and is the only COX-2 selective NSAID ever approved in the United States to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial. Tremeau plans to develop and commercialize rofecoxib for subsequent niche patient segments where it has a strong benefit to risk ratio versus other therapies.
“Tremeau’s strategy of matching rofecoxib’s profile to specific populations who can benefit from the drug is a good approach,” said Garret FitzGerald, chair of the department of Systems Pharmacology and Translational Therapeutics at the University of Pennsylvania Perelman School of Medicine.
November 22, 2017
Photo: Bradford Sippy, CEO of Tremeau