Tremeau Pharmaceuticals ACR Convergence 2022 Presentations Highlight Potential Path Forward for Historical VIOXX
11 Nov 2022
Drug Approval
Tremeau is presenting two abstracts, highlighting the following:
TRM-201 achieves comparable exposures of rofecoxib at a lower nominal dose (17.5 mg) compared to historical VIOXX 25 mg
Rofecoxib’s favorable gastrointestinal tolerability pro chronic off-label use of VIOXX’s acute dose (50 mg), leading to a perception of a unique CV safety risk
CONCORD, Mass.--(BUSINESS WIRE)--Tremeau Pharmaceuticals will present two abstracts highlighting a potential path forward for rofecoxib, the active ingredient in VIOXX, as a non-opioid treatment option during the American College of Rheumatology’s (ACR) Convergence Meeting in Philadelphia. The Massachusetts-based pharmaceutical company is focused on developing non-opioid pain treatments for patients with significant unmet needs.
“Many people living with pain cannot take traditional non-steroidal anti-inflammatory drugs (NSAIDs) due to their increased risk of bleeding and gastrointestinal ulcers,” said Tremeau Chief Development Officer Judith Boice. “These patients are often left with the inadequate options of living with pain, or resorting to opioids for pain relief.”
“Tremeau is developing TRM-201 (rofecoxib), a COX-2 selective NSAID, as a potential treatment option for people living with pain whose needs are not satisfied by traditional NSAIDs,” Dr. Boice added. “These posters highlight the work that Tremeau has done to establish a scientific bridge between TRM-201 and historical VIOXX, and why, at the right dose, rofecoxib carries no unique risk and several unique benefits compared to traditional NSAIDs.”
Both Tremeau abstracts include a virtual poster presentation:
Virtual Poster Presentations
Title: Establishing a Scientific Bridge to Historic VIOXX to Enable a Reintroduction of Rofecoxib: Pharmacokinetic Evaluation of TRM 201 (Rofecoxib)
Session: Sunday, Nov. 13, 9-10:30 a.m.
Summary of findings: TRM-201 achieves comparable exposure at a lower nominal dose (17.5 mg) compared to the historic data for 25 mg of the previously marketed rofecoxib (VIOXX), with a shorter Tmax. These data suggest that TRM-201 has a higher bioavailability and is more rapidly absorbed than VIOXX.
Title: Diagnosing the Cardiovascular Risk of VIOXX: A Place for Rofecoxib in Pain Management
Session: Monday, Nov. 14, 1-3 p.m.
Summary of findings: A combination of dose, clinical profile, and commercialization choices created a perception of a unique CV safety issue for VIOXX. Given its unique profile, rofecoxib ≤25 mg/day may be a viable treatment option in patient populations for whom traditional NSAIDs are avoided and where opioids are frequently used.
Both abstracts were published in an online supplement of Arthritis and Rheumatology.
About TRM-201 (Rofecoxib)
TRM-201 is an investigational non-opioid pain treatment containing rofecoxib. Previously marketed as VIOXX, rofecoxib was shown to be a highly potent cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug, or NSAID, with a well-established efficacy pro multiple indications. Rofecoxib has been shown to have greater blood-brain barrier penetration than any COX-2 selective NSAID currently available in the U.S. Rofecoxib was 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 FDA that it has established a comparable level of rofecoxib exposure for TRM-201 compared with the previously marketed version of VIOXX.
About Tremeau Pharmaceuticals
Tremeau is a Massachusetts-based pharmaceutical company focused on providing non-opioid pain treatments for patients with significant unmet needs.
Tremeau’s unique approach to acute and chronic pain in select conditions is rooted in the mechanism of action, documented efficacy, and clinically differentiated pro COX-2 selective NSAIDs.
Tremeau’s lead clinical stage product, TRM-201 (rofecoxib), is a COX-2 selective NSAID and a potent non-opioid analgesic with a well-established benefit-risk profile.
VIOXX is a registered trademark of Tremeau Pharmaceuticals, Inc.
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