MedRx : Prospect of NDA Re-Submission for MRX-5LBT

News Release Dated October 10, 2023

MEDRx Co., Ltd.

Yonehiro Matsumura, CEO

Stock code: 4586, TSE Growth

Prospect of NDA Re-Submission for MRX-5LBT

MEDRx has decided to re-submit the New Drug Application (NDA) for MRX-5LBT, a medicated patch with lidocaine*1 that will use the proprietary name Lydolyte, with re-analysis of existing data without additional study throuth examining a portion of non-clinical data pointed from the U.S. Food and Drug Administration in the Complete Response Letter with a jointly development partner D. Western Therapeutics Institute, Inc. The NDA re-submission will be done in 2023

MRX-5LBT is a new type of lidocaine patch for the treatment of post-herpetic neuralgia that uses the ILTS® (Ionic Liquid Transdermal System), an exclusive MEDRx technology incorporating the company's ionic liquid*2 expertise. By developing this new patch, which targets the market for the Lidoderm® lidocaine patch, MEDRx plans to further enlarge this market. Results of clinical trials indicate that MRX-5LBT has excellent prospects in the lidocaine patch market due to reduced skin irritation, firm adhesion to the skin and the strength to remain on the skin even during physical activity, compared with a targeted model Lidoderm®. In the United States, sales of lidocaine patches were USD 264 million in 2022*3.

Lidocaine is a type of local anesthetic that reduces pain by blocking the transmission of pain signals at the ends of nerves.

*2 Ionic liquid

An ionic liquid is a salt with a melting point of not more than 100ºC and is also called a room temperature molten salt. Properties include a low melting point, high ion conductivity, high polarity, non-volatility and non- combustibility. Many applications are being examined for ionic liquids, including in solar cells and environmentally responsible reaction solvents. MEDRx was first in the world to discover that converting drugs into ionic liquids and dissolving drugs in ionic liquids can dramatically increase the transdermal permeability of these drugs. MEDRx has gained considerable knowledge involving ionic liquids. There is a library of ionic liquids that are believed to be safe by combining them with compounds that have already been used for human consumption. MEDRx has expertise in selecting ionic liquids that are best suited to increasing the transdermal permeability of targeted drugs. Furthermore, MEDRx has the know-how to produce drugs in a format that is easy to use (patches, ointments, etc.) while retaining the properties of ionic liquids that contain drugs. The exclusive technology for producing transdermal drugs incorporating this knowledge is called the Ionic Liquid Transdermal System (ILTS®).

*3 data source: IQVIA

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Contact: MEDRx Co., Ltd. Management Department E-mail: info@medrx.co.jp

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