ABOUT TPU-006
TPU-006 is an investigational non-NSAID, non-opioid analgesic patch designed to deliver dexmedetomidine for 4 days (or longer) and is being evaluated for its ability to provide continuous pain relief after surgery. Using our proprietary drug delivery technology, we believe TPU-006 will provide doctors with a simple and effective alternative to opioids for post-surgical pain management.
TPU-006 is designed to complement existing postoperative treatments, such as branded and generic options like Zynrelef®, Exparel®, Ketorolac, and Bupivacaine, rather than directly compete with them. Its unique 96-hour delivery profile sets it apart, making it the sole product suitable for both in-hospital and outpatient use, ultimately reducing opioid consumption and addressing a significant gap in postoperative pain management.
Teikoku recently announced positive topline results from a Phase 2 proof of concept study. The double-blind, placebo-controlled, single-dose study evaluated the analgesic efficacy and safety of TPU-006 after abdominoplasty surgery. A total of 167 patients had patches applied (either active or placebo).
The new analysis shows that treatment with TPU-006 resulted in statistically significantly lower pain scores and reduced use of opioid rescue medication compared with placebo. TPU-006 was well tolerated with no unexpected adverse events, little application site skin irritation, and minimal drowsiness. Patients treated with TPU-006 experienced less constipation and nausea likely due to reduced use of opioid rescue medication.
Additionally, Teikoku received Fast Track Designation on June 2023 for TPU-006.
ADDRESSING THE OPIOID CRISIS
Opioid overdose kills more than 136 Americans a day[1] and regulators are looking at every avenue to end the country’s addiction, including by reducing the overreliance on opioids for post-surgical pain management. The NIH found that post-surgical opioid dependence or overdoses affect roughly 2 per 1,000 opioid-naive surgical patients prescribed an opioid and followed for 5 years.[2]
We aim to end the cycle by stopping it before it starts. By ensuring patients receive analgesic dosing continuously, TPU-006 provides a bridge from hospital to home for post-surgical pain management. In those critical first few days, TPU-006 can provide doctors with an alternative to opioid prescriptions and NSAIDs.
As the country continues through the opioid epidemic, doctors and lawmakers need solutions to reduce overreliance on opioid treatments to curb the rate of addiction and death.
RESEARCH & DEVELOPMENT
Uncovering What’s Possible
As a global pharmaceutical company with deep expertise in dosage form development plus comprehensive manufacturing capabilities, we create both the formulations and the delivery mechanisms that bring first and best in class therapies to life.
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