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Government Health Agency News

FDA

Lidocaine topical system OK’d for post-herpetic neuralgia pain

October 7, 2025

card-image

Brand name: Bondlido

Generic name: lidocaine transdermal system 10%

Manufacturer: MEDRx Co.

Approval date: September 25, 2025

FDA has approved Bondlido (lidocaine topical system 10%) for the relief of pain associated with post-herpetic neuralgia in adults.

According to a manufacturer press release, Bondlido is a new type of lidocaine patch that uses the ILTS (Ionic Liquid Transdermal System), a proprietary technology.

Efficacy

Single-dose treatment with a different lidocaine topical system was compared to treatment with vehicle system (without lidocaine), and to no treatment (observation only) in a double-blind, crossover clinical trial with 35 post-herpetic neuralgia patients. Pain intensity and pain relief scores were evaluated periodically for 12 hours. Lidocaine topical system performed statistically better than vehicle system in terms of pain intensity from 4 to 12 hours.

Multiple-dose, two-week treatment with a different lidocaine topical system was also compared to vehicle system (without lidocaine) in a double-blind, crossover clinical trial of withdrawal-type design conducted in 32 patients, who were considered as responders to the open-label use of lidocaine topical system prior to the study. The constant type of pain was evaluated but not the pain induced by sensory stimuli (dysesthesia). Statistically significant differences favoring the lidocaine topical system were observed in terms of time to exit from the trial (14 vs. 3.8 days at p-value <0.001), daily average pain relief, and patient's preference of treatment. About half of the patients also took oral medication commonly used in the treatment of post-herpetic neuralgia. The extent of use of concomitant medication was similar between the two treatment groups.

Based on a clinical study in adults wearing Bondlido covering the thoracic dermatomes T8-T10, 98 of 100 topical systems applied exhibited 75% or greater surface area adhesion at all timepoints evaluated (every 3 hours) throughout the 12-hour wear period.

Safety

Common adverse reactions include application site reactions such as irritation, erythema, and pruritus.

Sources:

Bondlido (lidocaine topical system) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215029s000lbl.pdf Issued September 2025. Accessed October 5, 2025.

MRX-5LBT “Bondlido” approved in the US for the treatment of post-herpetic neuralgia. [News release]. 2025. https://contents.xj-storage.jp/xcontents/AS98942/071af81b/8835/4c7d/9ed6/13e5b8b09c8a/20250925084453420s.pdf

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