Treameau Looks to Bring Back Vioxx for Non-Opioid Pain Relief

December 16, 2020 - Tremeau Pharmaceuticals recently announced that Gurnet Point Capital will fund its non-opioid program to clinically develop its investigational drug, TRM-201.

Additionally, the funding will also support a Phase 3 trial of TRM-201, or rofecoxib, for hemophilic arthropathy (HA). Gurnet Point Capital is Tremeau’s primary investor. 

Currently, there are no medications in the US indicated to treat joint pain in individuals with bleeding disorders, but opioids are the most frequently used prescription treatment. 

However, opioids as a topline treatment present major challenges to patients, especially in the US. 

National Institutes of Health data from 2018 found that every day, 128 people die in the US after overdosing on opioids, including prescription pain relievers, heroin, and synthetic opioids like fentanyl.

Additionally, CDC estimated that the total economic burden of prescription opioid misuse in the US alone is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

“Patients with hemophilic arthropathy need an alternative to opioids,” Bradford C. Sippy, chief executive officer of Tremeau, said in the announcement. “TRM-201 could be this much-needed option, and the investment and support from Gurnet Point Capital will enable us to make our vision a reality.”

If approved, Rofecoxib would potentially be the first oral non-opioid pain treatment in over 15 years and the first specifically indicated for HA.

Caregivers are oftentimes hesitant to prescribe NSAIDS for hemophilia patients because it may increase bleeding risk, particularly very serious internal bleeding.

But Rofecoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) had no effect on bleeding time and was 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. 

In 2004, the drug was taken off the market due to concerns about patient safety. The withdrawal of the drug took away a vital treatment option, which had a negative impact on patient’s lives.

“Hemophilia treatment has advanced significantly but hemophilic arthropathy hasn’t gone away,” said David Moore, partner at Gurnet Point Capital. “We made this investment because we see an opportunity to provide a pain management option that’s long overdue to the bleeding disorder community.”

According to CDC data, hemophilia A affects 1 in 5,000 male births and about 400 babies are born with hemophilia A each year.

Additional data based on patients receiving hemophilia treatment in centers between 2012 and 2018 found that as many as 33,000 males in the US are currently living with the disorder.

Back in 1999, FDA approved Rofecoxib, formally known as Vioxx, for the treatment of acute, osteoarthritis-induced pain and for the treatment of pain associated with rheumatoid arthritis and migraine. 

But studies released after the approval found that the drug elicited increased cardiovascular and thrombotic complications. Additionally, reports stated that Merck and Co., which manufactured the drug, misrepresented study results that downplayed the risk of Rofecoxib.

More recently, FDA granted orphan drug designation to Rofecoxib for the treatment of hemophilic arthropathy. 

The FDA designation added a potential benefit although the drug has not yet received FDA approval. 

A June 2020 Harvard Law press release emphasized that Rofecoxib could make a comeback this year.

Researchers used an example of a large cohort study that found that the odds for ratios for acute myocardial infarction were 1.48 for ibuprofen and 1.58 for rofecoxib. 

“The modest difference in the point estimates of risk with the potential for additional mitigation strategies suggests that sufficient clinical equipoise exists to justify a clinical trial,” researchers said. “Development and appropriate prescribing of this medication are worthy of further study.”