Dwestern Therapeutics' nerve pain drug DW-5LBT gains FDA acceptance

** Dwestern Therapeutics Institute (TSE:4576) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for DW-5LBT (Lidocaine patch; brand name: Lydolyte), a treatment for post-herpetic neuralgia, co-developed with MedRx. The resubmitted application, initially filed on March 25, 2025, has now been deemed complete by the FDA, triggering a full-scale review with a Prescription Drug User Fee Act (PDUFA) target action date of September 24, 2025. DW-5LBT utilizes MedRx's proprietary ionic liquid transdermal system (ILTS) technology. While this development will not impact the fiscal year ending December 2025, Dwestern anticipates contributing to the improvement of earnings over the medium to long term. DW-5LBT is targeted to penetrate the market as a superior product to Lidoderm®, the leading benchmark product, with less skin irritation, superior adhesive strength, and retention of adhesive strength even during exercise. The US market for lidocaine patch products was estimated to be worth about USD 193 million in 2023.