TPU-006 is an investigational non-opioid analgesic designed to deliver dexmedetomidine for 3 days or longer and is being evaluated for its ability to provide continuous pain relief after surgery. Based on Teikoku’s transdermal technology, TPU-006 is anticipated to play a central role in pain management.
Experts say the United States is in the throes of an opioid abuse epidemic, causing 91 overdose deaths each day. Lawmakers, regulators and drug makers have been working on ways to arrest the abuse, which experts partly attribute to the unrestricted prescription of painkillers.
Teikoku believes TPU-006 may help reduce the dependency on opioid-based medications following surgery
Potential Advantages of TPU-006
- Improve postoperative pain control in a wide variety of surgical procedures
- Reduce the use of postoperative opioids and their attendant side effects
- Convenience, ease of administration, hence better patient compliance
- Inpatient or outpatient setting
TPU-006 Recently completed a proof of concept (POC) study in Australia. The POC study was a double-blind, placebo-controlled, single-dose study to evaluate the analgesic efficacy and safety of TPU-006 after bunionectomy surgery. Patients who met the enrollment criteria were randomized to either an active or a placebo patch, and a total of 87 patients had patches applied (either active or placebo). The preliminary results demonstrate efficacy across several parameters, and no unexpected safety events were observed in a postoperative setting.
The statistically significant efficacy findings for the active arm include lower pain scores and less opioid rescue medication over the course of the study.
Dexmedetomidine is a selective α2-adrenergic agonist, which is part of a family of agonists that are frequently used for sedation, muscle relaxation, and analgesia. Dexmedetomidine is commercially available as Precedex® (dexmedetomidine hydrochloride) Injection for intravenous use.
About the Postoperative Market1
The global pain market was valued at $28.6 billion in 2010 and is projected to increase at a 3% CAGR to $35.1 billion in 2017. It has huge growth potential due to an increase in the aging population (2% in the U.S.). The postoperative pain market has been projected to be approximately one-fifth of the total market ($5.9 billion).
Sources: 1 GBI Research 2011, Pain Management Therapeutics Market 2017