Tremeau Pharmaceuticals ASH 2021 Presentations Highlight Unmet Need for Non-Opioid Pain Treatments for Patients with Bleeding Disorders

Tremeau is presenting three abstracts, highlighting the following:

• Claims data analysis finds that opioids are the most frequently used treatment for hemophilic arthropathy
• A detailed look at the Phase III clinical trial design for rofecoxib for the treatment of hemophilic arthropathy
• Patient-reported data suggesting high prevalence of migraine in people with von Willebrand disease

CONCORD, Mass.--(BUSINESS WIRE)--Tremeau Pharmaceuticals will present three abstracts highlighting the need for new non-opioid treatment options for bleeding disorder patients during the 63rd American Society of Hematology Annual Meeting and Exposition in Atlanta. The Massachusetts-based pharmaceutical company is focused on providing non-opioid pain treatments for well-defined patient populations with significant unmet needs.

“People with bleeding disorders have been left behind by the current standard of care in pain control,” said Tremeau Chief Development Officer Judith Boice. “These patients avoid traditional non-steroidal anti-inflammatory drugs due to their increased risk of bleeding and gastrointestinal ulcers.”

“Tremeau is developing TRM-201 (rofecoxib), a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), as a potential new treatment option for people with bleeding disorders who also suffer from painful conditions,” Dr. Boice added. “Rofecoxib has been shown to have no effect on platelet aggregation and is the only COX-2 selective NSAID ever approved in the US to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial."

The three Tremeau abstracts include a poster presentation and two online-only presentations:

Poster Presentation

Title: Profile of Pain Medication Use in Hemophilia and Hemarthrosis: An Analysis of a Pharmacy Claims Database

• Session: Monday, Dec. 13, 6-8 p.m.; Georgia World Congress Center, Hall B5
• Summary of findings: A cross-sectional prescription claims data analysis reflects broad use of opioids and traditional NSAIDs, underscoring limited pain management options available for hemophilia patients and highlighting the need to identify and develop alternate forms of chronic pain medications for this population.

Online-Only Presentations

Title: Assessment of TRM-201 (Rofecoxib) Efficacy and Safety for Chronic Pain in Hemophilic Arthropathy: The Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy (RESET-HA), a Randomized, Double-Blind Placebo-Controlled Phase III Clinical Trial

• Summary: Description of design of RESET-HA, a study intended to evaluate the efficacy and safety of TRM-201 in patients with HA and the first Phase III trial ever conducted to assess a treatment for HA pain.

Title: Prevalence of Acute and Chronic Migraine Among Patients with Von Willebrand Disease

• Summary: Fifty-seven percent of VWD patients surveyed (n=75) reported being diagnosed with migraine, a much higher rate than in the general population, suggesting that VWD patients are more susceptible to migraine.

Both online-only presentations were published in ASH’s November supplemental issue of Blood.

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 profile in multiple indications, including acute migraine. 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 well-defined patient populations 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 profile of 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.