SAN JOSE, September 6, 2023 /PRNewswire/ — Teikoku Pharma USA, a global pharmaceutical company, today announced positive results from its Phase 2 proof-of-concept study of TPU-006, a 4-day transdermal dexmedetomidine patch for postoperative 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, double-blind, placebo-controlled, single-dose study that evaluated the analgesic efficacy and safety of TPU-006 after bunionectomy surgery, which provided a clinically significant reduction in Pain and in opioid use. A total of 87 patients had patches applied (either active or placebo).
The new analysis shows that treatment with TPU-006 led to statistically significantly lower pain scores and reduced use of opioid rescue medication compared to placebo. TPU-006 was well tolerated with no unexpected adverse effects, little skin irritation at the application site, and minimal drowsiness. Patients treated with TPU-006 experienced less constipation and nausea likely due to reduced use of opioid rescue medications.
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 opioid-free treatment option for clinicians,” he said. Paul Morey, 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 toward our goal from day 1 – to develop a best-in-class treatment that can improve the overall The hope is that TPU-006 will both address pain and reduce in-hospital and outpatient opioid use, making it a very unique treatment option.”
About TPU-006D
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 marketed as Precedex® (dexmedetomidine hydrochloride) injection for intravenous use indicated for sedation, muscle relaxation and analgesia and Igalmi™ (Dexmedetomidine sublingual film) is indicated for the acute treatment of agitation associated with Schizophrenia or Bipolar II disorder.
About Teikoku Pharma USAInc.
Teikoku Pharma USAInc., located at San Jose, Californiais a wholly owned subsidiary of Teikoku Seiyaku Co., Ltd. of Japan. A global pharmaceutical company focused on developing new, best-in-class therapeutic solutions for important 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 postherpetic neuralgia in the United States and Versatis® in Europe and Latin Americaand Docetaxel Injection without alcohol.
CONTACT:
Francisco Bezar
[email protected]
SOURCE Teikoku Pharma USAInc.
