The Food and Drug Administration (FDA) has granted TRM-201 (rofecoxib; Tremeau Pharmaceuticals) orphan drug designation for the treatment of hemophilic arthropathy (HA), a degenerative joint disease in patients with hemophilia.

Currently, there is no approved treatment for HA in the United States. High potency opioids are the standard of care and traditional NSAIDs are not recommended in this patient group due to the risk of gastrointestinal ulcers and effects on platelet aggregation. 

TRM-201, a highly potent COX-2 selective non-steroidal anti-inflammatory drug (NSAID), has a well-established efficacy profile. The non-opioid drug candidate exerts no effect on bleeding time vs. placebo and is the only COX-2 selective NSAID that has demonstrated a reduced risk of gastrointestinal bleeding vs. a traditional NSAID in a controlled trial. 

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“With its well characterized, non-narcotic efficacy profile and lack of anti-platelet effect, rofecoxib is potentially well suited for patients suffering from hemophilic arthropathy,” Stacy Croteau, MD, MMS, Associate Director of the Boston Hemophilia Center, stated. 

The Company plans to develop rofecoxib for the treatment of HA and other specific patient groups where it has a strong benefit-risk ratio compared to other therapies.

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