Industry observation: Phase II clinical results of Imperial Pharmaceuticals dexmedetomidine patch positive
Click:178  Update time:2023-10-13  【Close


Image source: Teikoku Pharma USA official website


The global pharmaceutical company Teikoku Pharma USA announced in September 2023 the positive results of its clinical phase 2 proof of concept study (NCT04242407). TPU-006 (a 4-day dexmedetomidine transdermal patch for postoperative pain) was evaluated in a double-blind, placebo-controlled, single dose study to evaluate the analgesic effect and safety of TPU-006 after abdominal plastic surgery. A total of 167 patients received patch therapy (active medication or placebo).


The company previously reported positive top line results from a phase II study (NCT02953054) of a double blind, placebo controlled, single dose study, with a total of 87 patients receiving patch therapy (active drug or placebo). This study evaluated the analgesic efficacy and safety of TPU-006 after thumb bursitis resection surgery, with clinically significant reductions in pain and opioid use.


The new clinical trial results indicate that the treatment group TPU-006 significantly reduced pain scores and reduced the use of opioid remedies compared to placebo. TPU-006 has good tolerance, no unexpected adverse events, minimal skin irritation at the application site, and few side effects of drowsiness. Patients receiving TPU-006 treatment also experience a corresponding reduction in adverse reactions such as constipation and nausea due to reduced use of opioid drugs.


TPU-006 has obtained the qualification to enter the FDA rapid review channel

In June of this year, TPU-006 obtained the qualification to enter the FDA rapid review channel. The results of the second phase of concept validation research have validated the clinical application potential of TPU-006, Teikoku Pharma USA President and CEO Paul Mori stated: Our success in abdominal plastic surgery is an important and highly relevant surgical model that has been proven challenging for other analgesics and represents the goal we set from day one - to develop a first-class treatment method that can improve the overall postoperative experience of patients. The hope is to address pain and reduce the use of opioids in hospitals and clinics with TPU-006, making it a non opioid approach Unique treatment options. Abdominal plastic surgery is an important and highly relevant surgical model, and our successful validation research is an important milestone in this project. The fact that TPU-006 has clinical value for existing analgesic treatment methods has been proven. Developing a first-class therapeutic drug to improve the overall postoperative experience of patients is the original intention of our company's research and development. We hope that TPU-006 can not only solve pain problems but also reduce the use of opioids in hospitals and outpatient settings, making it a very unique treatment option.


About TPU-006

TPU-006 is a transdermal system under study that can deliver dexmedetomidine (a selective drug) in a single use α 2 adrenergic agonists) for up to four days. The existing market product of dexmedetomidine is Precedex ® Intravenous injection of dexmedetomidine hydrochloride for sedation, muscle relaxation, and pain relief, as well as Igalmi ™ (Dexmetomidine sublingual membrane), used for acute treatment of restlessness related to schizophrenia or type I or II bipolar disorder.


About Imperial Pharmaceuticals USA

Teikoku Pharma USA, Inc. is located in San Jose, California and is a wholly-owned subsidiary of Imperial Japan Pharmaceutical Co., Ltd. A global pharmaceutical company focused on developing innovative and first-class treatment solutions, dedicated to addressing the significant unmet needs of patients. Teikoku also develops and manufactures drugs based on proprietary drug delivery platform technology.


The main products of Imperial Pharmaceuticals include Lidoderm, which is used in the United States to treat postherpetic neuralgia ® Versatis (lidocaine 5% patch), used in Europe and Latin America to treat postherpetic neuralgia ® (Lidocaine 5% patch), as well as docetaxel alcohol free injection.


Lindmik's viewpoint

Registration of dexmedetomidine transdermal preparations in Chinese Mainland


Data source: Wuxu Data

The clinical registration application for two related varieties of Renfu is worth noting that they are both registered according to Class 2.1 of chemical drugs and have been approved by NMPD.


Registration and filing of clinical trials in Chinese Mainland


Data source: Wuxu Data


Currently, there are no transdermal formulations of dexmedetomidine on the global market. Imperial Pharmaceuticals' research and development indications are for postoperative pain, while clinical trials published by domestic companies show that it is used for perioperative pain relief and improves the sleep quality of perioperative patients. We will continue to pay attention to which project can be successfully approved for marketing.



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Lindmik Pharmaceutical(Suzhou)Co.,Ltd is a high-tech pharmaceutical enterprise focusing on the research and development, production and sales of innovative pharmaceutical preparations.Equipped with a number of its own innovative R&D platform of dosage forms, including the transdermal drug delivery system, and at the same time, actively introducing the world’s leading nano-based drug delivery, microspheres drug delivery and other cutting-edge pharmaceutical technologies by means of “license in”, the company is a new rapidly developing company pharmaceutical companies that catches people’s eyes.

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