TPU-006, our most advanced transdermal pain management product, is Phase 3 ready. It is a non-opioid, non-NSAID analgesic patch designed for managing post-surgical pain.
TPU-006 is an investigational non-opioid, non-NSAID 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 recently completed a positive Phase 2 proof of concept study of TPU-006, a 4-day dexmedetomidine transdermal patch for Post Surgical Pain. 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 data complements our positive topline results from a Phase 2 study double-blind, placebo-controlled, single-dose study that evaluated the analgesic efficacy and safety of TPU-006 after bunionectomy surgery which provided clinically meaningful reduction in Pain and opioid use. A total of 87 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.
Opioids 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 and effortlessly, 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.
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.
[1] Drug Overdose Death Rates, US National Center for Drug Abuse Statistics, 2021
[2] “Opioid Dependence and Overdose After Surgery: Rate, Risk Factors, and Reasons,” Annals of Surgery, 2022, vol. 276, no. 3.
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