Teikoku Pharma Announces Positive Results from Phase 2 Clinical Trial of TPU-006

Teikoku Pharma announced positive topline results from its Phase 2 proof of concept study of TPU-006, a three-day dexmedetomidine transdermal patch, a novel drug delivery system with a non-opioid active moiety for the management of post-surgical pain. The preliminary results demonstrate that the patch provides effective pain control across several parameters and produced no unexpected safety events in a postoperative setting.

The double-blind, placebo-controlled, single-dose study evaluated the analgesic efficacy and safety of TPU-006 after bunionectomy surgery. A total of 87 patients had patches applied (either active or placebo).

Treatment with TPU-006 showed statistically significant key findings for lower pain scores and reduced use of opioid rescue medication compared with placebo, over the course of the study. TPU-006 was well tolerated, with no unexpected serious adverse events, minimal to no application site skin irritation, or drowsiness. Patients treated with TPU-006 experienced less constipation and nausea due to reduced use of opioid rescue medication.

"TPU-006 offers the potential to improve current post-operative or chronic pain management practices. It also provides a much-needed strategy to reduce the use of narcotic painkillers.  The ease of administration (application and removal), as seen in this study, means that the TPU-006 patch can be used in both the inpatient and outpatient setting," said Jutaro Shudo, Chief Science Officer of Teikoku Pharma.

TPU-006 is an investigational transdermal product, intended to deliver dexmedetomidine for up to several days from a single application. 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.