SAN JOSE, Sept. 6, 2023 /PRNewswire/ — Teikoku Pharma USA, a global pharmaceutical company, today announced positive topline results from its 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 company previously reported 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.
In June of this year, Teikoku received Fast Track Designation for TPU-006
Today’s results validate the potential for TPU-006 to become an innovative non-opioid treatment option for clinicians,” said Paul Mori, President and CEO. “Our success in Abdominoplasty, is an important and highly relevant surgical model that has proven challenging for other analgesics, and represents an important step towards the goal we set from day 1 – to develop a best-in-class therapeutic that can improve the whole patient experience after surgery. The hope is for TPU-006 to address both pain and reduce opioid use in the hospital and outpatient settings making it a very unique therapeutic option.”
TPU-006 is an investigational transdermal system that delivers dexmedetomidine, a selective α2-adrenergic agonist, for up to four days from a single application. Dexmedetomidine is commercially available as Precedex® (dexmedetomidine hydrochloride) Injection for intravenous use indicated for sedation, muscle relaxation, and analgesia and Igalmi™ (Dexmedetomidine sublingual film) indicated for the acute treatment of agitation associated with Schizophrenia or Bipolar I or II disorder.
About Teikoku Pharma USA, Inc.
Teikoku Pharma USA, Inc., located in San Jose, California, is a wholly-owned subsidiary of Teikoku Seiyaku Co., Ltd. of Japan. A global pharmaceutical company that focuses on developing novel best-in-class treatment solutions for significant unmet patient needs. Teikoku also develops and manufactures pharmaceutical products based on proprietary delivery platform technologies.
Teikoku Pharma’s main products include: Lidoderm® (Lidocaine 5% Patch) for post-herpetic neuralgia in the United States and Versatis® in Europe and Latin America, and Docetaxel Alcohol Free Injection.
SOURCE Teikoku Pharma USA, Inc.