The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation.

The delivery candidate, called TPU-006, delivers dexmedetomidine for up to four days. Dexmedetomidine is a common non-opioid analgesic that activates alpha-2 receptors, which inhibits the release of noradrenaline and subsequent propagation of pain signals. 

Teikoku Pharma, a US subsidiary of Japan-based Teikoku Seiyaku, is supporting the candidate’s route to market with a Phase IIb trial (NCT05412992) being conducted in clinical centres across California and Utah. With an estimated enrollment of 182 patients undergoing abdominoplasty, the company will present data comparing its transdermal system with a placebo in Q3 of 2023.

Opioid-based medication remains the go-to option for pain management. However, the opioid epidemic in the US has catalysed a shift in focus to alternatives. Teikoku Pharma says that it believes TPU-006 might help reduce opioid-based dependency for post-surgical pain. It cites convenience, ease of administration, and the resulting improved patient compliance as advantages of its transdermal system.

Dexmedetomidine is commercially available as Precedex, marketed by Pfizer. Recently, the FDA granted approval for Milla Pharmaceutical’s generic version of the drug to help with shortages in the US.

Teikoku Pharma has a contentious history with marketing transdermal delivery systems in the US. In 2018, it was, along with its parent company Teikoku Seiyaku, caught up in a legal battle with 24 US states after it allegedly moved to create a monopoly on one of its products, a lidocaine patch.

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“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, Teikoku’s president and CEO.

“We look forward to working closely with the FDA to bring TPU-006 to clinicians and patients as soon as possible.”