News Release Dated April 2, 2025
MEDRx Co., Ltd.
Yonehiro Matsumura, CEO
Stock code: 4586, TSE Growth
FDA Acceptance of New Drug Application for MRX-5LBT (“Lydolyte”)
MEDRx announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for MRX-5LBT, a medicated patch with lidocaine*1that will use the proprietary name Lydolyte. The MEDRx Group and D. Western Therapeutics Institute, Inc. are jointly developing this drug in the United States. The target action date under the Prescription Drug User Fee Act (PDUFA) is September 24, 2025.
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*2expertise.
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 193 million in 2023*3.
The acceptance of this new drug application will have no effect on the forecast for the current fiscal year but are expected to make a medium to long-term contribution to results of operations.
Note: This document has been translated from the Japanese original for reference purposes only. In the event of any discrepancy between this translated document and the Japanese original, the original shall prevail.
*1 Lidocaine
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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