Teikoku Pharma USA Announces Positive Topline Results From Phase 2 Clinical Trial Of TPU-006, Non Opioid Pain Management Patch In Bunionectomy Surgery
SAN JOSE, Calif., Aug. 22, 2017—Teikoku Pharma USA, Inc. (Teikoku Pharma) today announced positive topline results from its Phase 2 proof of concept study of TPU-006, a 3-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.
“We are pleased to see the efficacy of TPU-006 in this well controlled Phase 2 study. As the pace of the opioid epidemic continues to increase, we believe TPU-006 may help reduce the dependency on opioid-based medications following surgery,” added Paul Mori, President and Chief Executive 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.
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).
About Teikoku Pharma USA, Inc.
Teikoku Pharma USA, Inc. is located in San Jose, California, a wholly-owned subsidiary of Teikoku Seiyaku Co., Ltd. of Japan. This international specialty pharmaceutical company is focused on developing novel best-in-class treatment solutions to address some of the biggest unmet patient needs. It 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 [distributed by Endo Pharmaceuticals in the United States and Grunenthal GmbH in Europe and Latin America as Versatis®]; and Docetaxel Alcohol-Free Injection [distributed by Eagle Pharmaceuticals in the United States].
Source: Teikoku Pharma USA, Inc.
Posted: August 2017
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
- Monthly Update Archive
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.