Teikoku Pharma granted FDA Fast Track Designation for TPU-006, a Novel 4-day Dexmedetomidine Transdermal System for Post Operative Pain Management

SAN JOSE, June 21, 2023 /PRNewswire/ -- Teikoku Pharma USA, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for TPU-006 in managing postoperative pain. TPU-006 is an investigational 4-day dexmedetomidine transdermal system, a novel drug delivery technology with a non-opioid active moiety for managing post-surgical pain.

"We are excited by the FDA's decision to grant a Fast Track Designation for TPU-006 to address a serious unmet need and serve as a meaningful therapeutic option for patients with post-surgical pain," said Paul Mori, President and Chief Executive Officer of Teikoku. "We look forward to working closely with the FDA to bring TPU-006 to clinicians and patients as soon as possible."

TPU-006's evaluation involves a randomized, double-blind Phase 2b clinical trial in patients undergoing abdominoplasty to examine this agent's efficacy and safety. The Company expects results from this study in the third quarter of 2023. These data will complement TPU-006's positive results from a randomized confirmatory Phase 2 study in bunionectomy.

About Fast Track Designation

The FDA offers Fast Track Designation to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill unmet medical needs. This classification enables drugs to reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

About TPU-006

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.

CONTACT:
Francisco Bejar 
FBejar@teikokuusa.com