The Food and Drug Administration (FDA) has granted Fast Track designation to Teikoku Pharma’s TPU-006 for the management of postoperative pain.
TPU-006 is an investigational transdermal system containing dexmedetomidine, a selective α2-adrenergic agonist. A single application is expected to deliver dexmedetomidine for 4 days. Transparency Tpu
The FDA’s designation was based on data from a placebo-controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT02953054), which included patients with acute moderate to severe pain following unilateral bunionectomy. Findings showed that patients treated with TPU-006 had lower pain scores and used less opioid rescue medication compared with placebo.
The Company is also investigating the safety and efficacy of TPU-006 in a phase 2 trial involving participants who have undergone abdominoplasty (ClinicalTrials.gov Identifier: NCT04242407). Results from this study are expected in the third quarter of 2023.
“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 postsurgical 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.” The FDA has previously approved other forms of dexmedetomidine including an injectable product for sedation, muscle relaxation, and analgesia and a sublingual film for agitation associated with schizophrenia or bipolar disorder.
Teikoku Pharma granted FDA Fast Track designation for TPU-006, a novel 4-day dexmedetomidine transdermal system for postoperative pain management. News release. June 21, 2023. https://www.prnewswire.com/news-releases/teikoku-pharma-granted-fda-fast-track-designation-for-tpu-006-a-novel-4-day-dexmedetomidine-transdermal-system-for-post-operative-pain-management-301856234.html.
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