MedRx receives FDA acceptance for MRX-5LBT application

MedRx Co., Ltd. (TSE:4586) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MRX-5LBT (lidocaine tape, brand name Lydolyte), a treatment for postherpetic neuralgia jointly developed with De Western Therapeutics Institute. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of September 24, 2025 (U.S. time). MRX-5LBT utilizes MedRx's proprietary ILTS® technology and targets the Lidoderm® market, while also aiming for expansion into new markets. U.S. lidocaine patch market was estimated at approximately USD 193 million in 2023. While there is no immediate impact on MedRx’s current earnings forecast, the company anticipates a positive contribution to long-term performance.