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Assets

At Tremeau, we focus on patient populations whose pain management needs are not well-satisfied by the current standard of care. Our unique approach to acute and chronic pain in select conditions is rooted in the mechanism of action, documented efficacy in painful inflammatory conditions, and clinically differentiated profile of COX-2 selective NSAIDs.

Tremeau believes that the multiple, often industry-independent, scientific evaluations of the past 15+ years strongly suggest a re-examination of the potential utility of rofecoxib and etoricoxib. This is especially true with indications in which a COX-2 selective NSAID may provide therapeutic advantages over other standards of care, such as opioids.

About TRM-201 (rofecoxib)

TRM-201 is an investigational non-opioid pain treatment containing rofecoxib. Previously marketed as VIOXX, rofecoxib has been shown to be a highly potent COX-2 selective NSAID, with a well-established efficacy profile in multiple indications. Rofecoxib has been shown to have no effect on bleeding time and was the only COX-2 selective NSAID ever approved in the U.S. to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial. VIOXX was voluntarily withdrawn from the market in 2004 due to concerns about cardiovascular safety. It has since been demonstrated in multiple, often industry-independent studies that cardiovascular safety is a dose- and duration-dependent risk of all NSAIDs.

Tremeau has gained agreement with the FDA that it has established a comparable level of rofecoxib exposure for TRM-201 compared with the previously marketed version of VIOXX.

TRM-201 is protected by U.S. Patent No. 10,945,992 (expiring May 2040), which broadly covers the PK profile of 17.5mg solid dosage forms of rofecoxib, and U.S. Patent No. 10,987,337 (expiring December 2039), which broadly covers highly purified rofecoxib.

About TRM-362 (deuterated etoricoxib)

TRM-362 (d3-etoricoxib) is an investigational non-opioid pain treatment containing deuterated etoricoxib.

Etoricoxib is a highly selective COX-2 NSAID with a well-established benefit/risk profile. It has demonstrated efficacy and tolerability superior to opioids in select acute pain conditions, with an onset of action in as early as 24 minutes and has no effect on platelet aggregation. It is broadly available outside of the U.S.

Deuterium is a naturally occurring, stable isotope of hydrogen, with an additional neutron in its nucleus. Selectively substituting hydrogen with deuterium, or deuteration, may alter a molecule’s metabolic profile while maintaining its core pharmacodynamic characteristics.

TRM-362 is protected by U.S. Patent No. 11,161,833, which provides compound patent protection through 2041.