ZTlido Bioequivalent to Lidoderm Patch, With Better Adhesion Profile
ZTlido™ is an anhydrous, single-layer drug-in-adhesive system that has been approved by the US Food and Drug Administration for treating postherpetic neuralgia-associated pain.
|The following article is part of conference coverage from the PAINWeek 2018 conference in Las Vegas, Nevada. Clinical Pain Advisor's staff will be reporting breaking news associated with research conducted by leading experts in pain medicine. Check back for the latest news from PAINWeek 2018.|
LAS VEGAS — A topical lidocaine (1.8%, 36 mg) delivery system (ZTlido™) may be safe, effective and well-tolerated, and be bioequivalent to a lidocaine patch (Lidoderm®, 5%, 700 mg), with superior adhesion properties, according to a study presented during the 2018 PAINWeek conference, held September 4-8.
ZTlido is an anhydrous, single-layer drug-in-adhesive system that has been approved by the US Food and Drug Administration (FDA) for treating postherpetic neuralgia-associated pain.
A total of 54 healthy adults were randomly assigned to receive ZTlido or Lidoderm in a comparative pharmacokinetic trial. A 3-patch single dose was administered to all participants over a 12-hour period, and lidocaine plasma concentrations were determined using serial blood sampling, with samples taken prior to drug administration and then up to 48 hours after drug administration.
Several pharmacokinetic parameters — area under the curve (AUC), and peak serum concentration (Cmax) — were evaluated to determine bioequivalency between the 2 systems. In addition, adhesion, safety, and skin irritation profiles were assessed for both systems.
Bioequivalency was established between the 2 systems, based on the geometric mean ratios of Cmax and AUC showing 90% confidence intervals that were within the 80% to 125% regulatory range. ZTlido had greater mean adhesion at 12 hours, compared with Lidoderm (mean score, 0.22 vs 0.86, respectively; P <.0001; scores on the 0-4 FDA scale; score of 0 indicating ≥90% adhesion; score of 4 indicating total detachment). None vs 13 of the study participants had a score >2 (indicative of <75% adhesion) with ZTlido vs Lidoderm, respectively. One adverse event — deemed unrelated to treatment — was reported in each group, and participants in the 2 groups had similar skin irritation scores.
The ZTlido system achieved bioequivalence to and better adhesion than the Lidoderm patch, with a comparable safety profile, making it an excellent choice as a substitute for the standard lidocaine patch in patients with pain-related to postherpetic neuralgia.
Patel K, Gudin J, Vought K, et al. A randomized, comparative pharmacokinetic (PK) study of ZTlido™ lidocaine topical system 1.8% (36 mg) versus Lidoderm® lidocaine patch 5% (700 mg). Presented at: PAINWeek 2018; September 4-8, 2018; Las Vegas, NV. Poster 63.
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