Tuesday, October 26, 2021
Tremeau Pharmaceuticals today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 17/240,446. Once issued, the patent will provide composition of matter patent protection for Tremeau’s novel deuterium-enriched etoricoxib compound, TRM-362 (d3-etoricoxib), through at least April 2041.
Etoricoxib is a highly selective cyclooxygenase-2 (COX-2) non-steroidal anti-inflammatory drug (NSAID) with a well-established benefit/risk profile. It has demonstrated efficacy and tolerability superior to opioids in select acute pain conditions1,2 with an onset of action in as early as 24 minutes, and has no effect on platelet aggregation.3 It is broadly available outside of the U.S.
In in vitro and animal studies, the pharmacokinetic profile of TRM-362 was highly differentiated from non-enriched etoricoxib, including achieving a 50% greater Cmax and a 50% higher exposure at an equivalent dose in a nonclinical cross-over study in dogs. These studies suggest that TRM-362 could provide similar or greater acute pain efficacy when compared to non-enriched etoricoxib, potentially at a lower dose.
Tremeau has gained formal feedback from FDA regarding the clinical and regulatory requirements to develop a COX-2 selective NSAID for acute pain conditions, and plans to rapidly advance TRM-362 as an opioid alternative for this indication. Tremeau believes that TRM-362 could serve as a powerful non-opioid pain product for patients in whom an increased risk of bleeding is a concern, such as those in the post-operative setting.
“Post-operative bleeding is a significant concern after surgery, and must be balanced with adequate pain management and DVT prophylaxis,” said Michael M. Alexiades, MD, Professor of Clinical Orthopaedic Surgery, Weill Cornell Medical College and Director, Department of Rehabilitation, Hospital for Special Surgery, New York City, NY. “The surgical community would welcome a more potent non-opioid pain medication that does not carry the bleeding risk of traditional NSAIDs.”
“Despite the significant and continuing unmet need for non-opioid pain medications, there has been little development of viable opioid alternatives. Based on etoricoxib’s well-known safety and efficacy profile and our preclinical studies to date, we believe that TRM-362 has the potential to be a best-in-class non-opioid treatment option for patients with acute pain,” said Bradford C. Sippy, Tremeau’s Chief Executive Officer. “A major design flaw of previous COX-2 selective NSAIDs and current opioid products is the easy, chronic access to doses intended only for acute use. We will work proactively with FDA to design a product for acute pain that ensures access only for short-term use.”