Lydolyte (lidocaine patch transdermal) / MEDRx, D. Western Therapeutics Institute - LARVOL DELTA

FDA Acceptance of New Drug Application for DW-5LBT (DWTI) - "D. Western Therapeutics Institute, Inc...are pleased to announce that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for DW-5LBT (Lidocaine...patch; brand name: Lydolyte), the treatment of post-herpetic neuralgia...This acceptance of the NDA means that the FDA has confirmed that the documents pertaining to the application are sufficiently complete during the post-submission review period and has begun a full-scale review. The target action date under the Prescription Drug User Fee Act (PDUFA) is September 24, 2025."

FDA filing • PDUFA • Neuralgia

De Western Therapeutics Institute announces policy for resubmission of nerve pain drug "DW-5LBT" [Google translation] (Nikkei) - "Regarding DW-5LBT...a treatment for post-herpetic neuralgia, which is being jointly developed in the United States by our company and MEDRx Co., Ltd...in our 'Notice of Receipt of Complete Response Letter (CRL) for DW-5LBT, a treatment for neuralgia,' dated July 12, 2024, we announced that we had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA)."

CRL • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

De Western Therapeutics Institute Receives Notification of Completion of Review for Nerve Pain Drug “DW-5LBT“ [Google translation] (Nikkei) - "Regarding 'DW-5LBT (lidocaine tape, trade name Lydolyte),' a treatment for post-herpetic nerve pain that is being jointly developed in the United States by our company and MEDRx Co., Ltd. (hereinafter referred to as 'MEDRx'), in our 'Notice regarding acceptance of U.S. regulatory application for DW-5LBT, a treatment for nerve pain,' dated January 31, 2024, we announced that the New Drug Application for this drug has been accepted by the U.S. Food and Drug Administration (FDA)."

FDA filing • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Medrex, MRX-5LBT: Acceptance of application for approval by US FDA [Google translation] (Nikkei) - "Regarding MRX-5LBT (lidocaine tape, trade name: Lydolyte), a post-herpetic nerve pain treatment drug jointly developed in the United States by our group and De Western Therapeutics Research Institute, Inc., the U.S. regulatory authority, American Foods Co., Ltd. We previously announced that we had resubmitted the New Drug Application (NDA) to the Food and Drug Administration (FDA) (January 12, 2024), but we have now announced that the FDA has accepted the application. I would like to inform you that."

NDA • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

De Western Therapeutics Institute applies for approval of nerve pain treatment drug “DW-5LBT” [Google translation] (Nikkei) - "The Company and Medrex Co., Ltd...are jointly developing in the United States, 'DW-5LBT (lidocaine tape, trade name: Lydolyte)', a treatment for post-herpetic nerve pain, will be announced in December 2023. In the February 25, 2020 issue titled 'Regarding the timing of the application for approval of the nerve pain treatment drug DW-5LBT,' the company announced that it is expected to proceed with reanalysis of the data and resubmit the application in January 2024."

NDA • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Medrex, outlook for MRX-5LBT reapplication [Google translation] (Nikkei) - "At the CRL, we were asked to resubmit some non-clinical data in accordance with FDA instructions....As a result of reviewing the instructions, we decided to comply with the FDA instructions by re-analyzing the data without conducting additional testing. I have come to the conclusion that I can handle it. In the future, we plan to proceed with reanalysis and resubmit the application within 2023."

NDA • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

De Western Therapeutics Institute notifies receipt of notification of review completion report for nerve pain treatment drug “DW-5LBT” (Nikkei) - "This product was jointly developed in the United States by our company and Medrex Co., Ltd. (hereinafter referred to as 'Medorex'). DW-5LBT (lidocaine (Note 1) tape, trade name), a post-herpetic nerve pain treatment drug....We have recently received a Complete Response Letter from the FDA. We would like to inform you of this. The Company and Medrex are currently reviewing the contents of the review completion report notification. We are currently reviewing the matter and will notify you as soon as future response policies and plans are decided. Please note that there will be no changes to the business forecast for the fiscal year ending December 2023 as a result of this matter."

FDA event • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

MEDRx Accepts US FDA Approval Application for MRX-5LBT [Google translation] (Nikkei) - "MRX-5LBT...a postherpetic nerve pain treatment drug jointly developed in the United States by the Group and De Western Therapeutics Institute, Inc. We had previously informed that we had resubmitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the United States (March 29, 2023). We will notify you that your application has been received. Acceptance of this new drug application means that the FDA has confirmed that the application documents are sufficiently complete during the review period after submission, and has begun full-scale review. In addition, the target date for review completion (PDUFA date) based on the Prescription Drug User Fee Act (PDUFA) has been set as September 28, 2023."

NDA • PDUFA date • CNS Disorders • Neuralgia • Pain

MEDRx Submits MRX-5LBT Approval Application [Google translation] (Nikkei) - "MRX-5LBT...a postherpetic nerve pain treatment drug jointly developed in the United States by the Group and De Western Therapeutics Institute, Inc. Regarding the tests pointed out by the Food and Drug Administration (FDA) as being necessary for obtaining approval, after agreeing with the FDA on the details of the tests, additional tests were conducted and good results were obtained, and the application was reapplied. (Feb. 10, 2023 earnings report). We are pleased to inform you that we have resubmitted the New Drug Application (NDA) to the FDA. The review period is scheduled to take about six months, but we will inform you of the schedule details as soon as we receive notification from the FDA."

NDA • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Medrec---Stop high bids, good results in additional study of nerve pain drug MRX-5LBT [Google translation] (Kabutan - Minkabu The Infonoid) - "Conducted an additional study in agreement with the U.S. Food and Drug Administration (FDA) on MRX-5LBT (lidocaine tape), a postherpetic nerve pain treatment drug jointly developed with D. Western Therapeutics Institute....It is announced that good results (preliminary figures) have been obtained. The FDA had pointed out that the study was necessary to obtain approval. The company plans to apply for approval in the first half of 2023, and expects to obtain approval in the second half of the year after a six-month review period."

Clinical data • NDA • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Featured news this morning! Focus on Kasumigaseki C, Arklands, Medrex, and more! [Google translation] (Kabutan - Minkabu The Infonoid) - "D. Western Therapeutics Institute...regarding postherpetic nerve pain treatment 'MRX-5LBT'...the U.S. Food and Drug Administration (The company had announced a policy of reapplying after conducting additional tests pointed out by the FDA as necessary for obtaining approval, but agreed with the FDA on the details of the tests. Going forward, we aim to apply for approval in the first half of 2023 and obtain approval in the second half of the same year."

FDA event • NDA • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

MEDRx and lidocaine patches aim to be approved in 2023 [Google translation] (Nikkei) - "At the briefing session, it was revealed that the schedule for obtaining approval for the local anesthetic lidocaine patch (MRX-5LBT), which was expected to be approved in the United States by 2021, was postponed in 2023."

NDA • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

MEDRx revised downward to expand deficit at the end of this term, deficit of 41% against net assets [Google translation] (Kabutan - Minkabu The Infonoid) - "The acquisition of US approval for MRX-5LBT (lidocaine tape, brand name Lydolyte), a treatment for neuropathic pain after herpes zoster, is expected to be delayed from next year onward, and De Western Co., Ltd. Milestone income from the D. Western Therapeutics Institute (DWTI) is expected to decline from next year onwards. As a result, sales decreased by 100 million yen"

Commercial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Do Lidocaine Patches Reduce Opioid Use in Acute Rib Fractures? (PubMed, Am Surg) - "In admitted trauma patients with acute rib fractures not requiring continuous intravenous opiates, lidocaine patch use was associated with a significant decrease in opiate utilization during the patients' hospital course."

Journal • Mood Disorders • Musculoskeletal Diseases • Orthopedics • Pain

[VIRTUAL] The Use Of Transdermal Lidocaine In A Newborn For Palliative Pain Control (ASA 2020) - "Methemoglobin levels were <1%. Despite scarce reports of transdermal lidocaine in newborns, it was used safely in this situation with limited options."

Anesthesia • Gastrointestinal Disorder • Pain

Retraction of "Clinical Efficacy of Ultrasound-Mediated Transdermal Lidocaine and Capsaicin Delivery for the Treatment of Allodynia Caused by Herpes Zoster". (PubMed, Pain Med) - No abstract available

Clinical • Journal • Herpes Zoster • Varicella Zoster

Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System (clinicaltrials.gov) - P=N/A; N=200; Recruiting; Sponsor: Aswan University Hospital; Not yet recruiting ➔ Recruiting

Clinical • Clinical data • Enrollment open

Transdermal Lidocaine for Pain Control During Hysterosalpingography (clinicaltrials.gov) - P=N/A; N=120; Recruiting; Sponsor: Aswan University Hospital; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infertility • Pain • Sexual Disorders

Transdermal patches of lidocaine/aspirin ionic liquid drug-loaded gelatin/polyvinyl alcohol composite film prepared by freeze-thawed procedure. (PubMed, An Acad Bras Cienc) - "Decomposition of the lidocaine/aspirin ionic liquid drug was found in the patch; however, the properties of the patch were not changed after drug loading. The patch controlled the drug release and showed good stability during the studied period of three months when kept at 4°C more than at ambient temperature and 45°C."

Journal

The OBstetric Lidocaine Patch (OBLido) Trial (clinicaltrials.gov) - P4; N=66; Completed; Sponsor: University of Wisconsin, Madison; Active, not recruiting ➔ Completed; Trial completion date: Mar 2020 ➔ Nov 2019

Clinical • Trial completion • Trial completion date • Genetic Disorders • Obesity • Obstetrics • Pain

Transdermal Lidocaine for Pain Control During Hysterosalpingography (clinicaltrials.gov) - P=N/A; N=120; Not yet recruiting; Sponsor: Aswan University Hospital

Clinical • New trial • Infertility • Pain • Sexual Disorders

Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy (clinicaltrials.gov) - P=N/A; N=200; Not yet recruiting; Sponsor: Aswan University Hospital

Clinical • New trial • Infertility • Pain • Sexual Disorders

Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System (clinicaltrials.gov) - P=N/A; N=200; Not yet recruiting; Sponsor: hany farouk

Clinical • Clinical data • New trial

Medrek---Significantly repulsive, application for new drug approval of neuropathic drug MRX-5LBT to US Food and Drug Administration [Google translation] (Reuters) - "Significant repulsion. Announced that it has submitted a new drug approval application to the US Food and Drug Administration for MRX-5LBT (lidocaine tape), a drug for post-herpetic neuralgia that is being co-developed in the US with De Western Therapy Institute 4576."

NDA • CNS Disorders • Neuralgia • Pain

Effect of 5% transdermal lidocaine patches on postoperative analgesia in dogs undergoing hemilaminectomy. (PubMed, J Small Anim Pract) - "In this setting, 5% lidocaine patches did not provide additional postoperative analgesia in dogs undergoing hemilaminectomy."

Journal • Anesthesia • Pain