BriOri BioTech Granted Patent for Topical Formulation of Vioxx

On Mar 10, 2022

BriOri BioTech, an emerging pre-clinical stage biotech company focused on developing a pipeline of opiate-free topical pain medications, announces its patent for “Topical Compositions Containing Rofecoxib (Vioxx) and Methods of Making and Using the Same” was issued on March 1, 2022. This patent covers a reformulation of Vioxx, a COX-2 specific NSAID, from an oral to topical formulation with the intention of alleviating osteoarthritis related pain of the knee and joint pain, and reducing the need for opioids in certain patient populations. With the global market for topical pain relief treatments estimated to be $8.8 billion in 2019 and projected to grow to $12.2 billion by 2027, BriOri BioTech aims to bring a safer and more effective solution to the market to meet a large unmet need.

Their novel topical reformulation of Vioxx (rofecoxib) called RelῩva, will likely be significantly safer than the oral NSAIDs due to a lower systemic exposure than OTC NSAIDs like Aleve or Advil or prescription COX-2 NSAIDs like Celebrex, while providing strong, 24-hour, non-addictive pain relief.

“Backed by a team with more than 150 years of combined experience in successful U.S. Food and Drug Administration (FDA) submissions and successful NSAID commercial development, we at BriOri are thrilled to be developing the next-generation topical osteoarthritis pain relieve drug with the potential to neutralize inflammatory pain and render opioid use obsolete for most people with osteoarthritis of the knee, which afflicts over 18 million people in the U.S. alone,” says Bruce Register, PhD and Founder and CEO of BriOri BioTech.

With more years of experience with NSAIDs and topical NSAIDs than any other private company and proven success in several development and commercialization arcs, the team at BriOri BioTech is working to repurpose oral NSAIDS to topical formulations. Oral therapeutic doses have been shown to cause gastrointestinal bleeds and cardiovascular events. These adverse side effects are dose dependent. The higher the dose the more GI and CV events. Topical NSAIDs applied to the point of pain will reduce the systemic exposure to help reduce serious adverse side effects while alleviating pain. The difficulty in making topical Vioxx is twofold, solubility of the drug and skin penetration. Our system of solvents solves both problems with FDA approved excipients and is now patented.

“Our goal was to bring Vioxx back as a topical treatment because it’s arguably the strongest analgesic ever approved by the FDA with the longest half-life. Vioxx was taken off the market in the United States because of the increased risk of cardiovascular events seen in very long-term studies, but at the time we didn’t know that every NSAID had the same profile. Since then, the FDA has put a black box warning on all NSAIDs about the increased risk of heart attacks, strokes, and GI bleeds due to the systemic exposure associated with oral dosing. It turns out that Vioxx was pulled prematurely. We are pleased to bring it back as a topical product with a lower systemic exposure to mitigate the risks while retaining efficacy,” states Bruce Register, PhD, CEO of BriOri BioTech.

BriOri BioTech’s pre-clinical research to date has indicated the company’s product formulation will most certainly outperform the competition. These findings include:

Better human skin penetration than competitors
Lower systemic exposure than oral dosing
Accumulates in the synovium more than oral dosing
Superior pain efficacy to oral dosing at 8 hours and 24 hours
Mini-pig Draize scores (skin irritation) all zero

“I’m thrilled to be granted a patent for the topical formulation of rofecoxib (Vioxx), a strong long-lasting COX-2 specific NSAID, so we can bring the millions suffering from osteoarthritis safe and effective relief,” concludes Register.