LIDODERM®: Proven efficacy in 2 pivotal trials1,2,3


In both studies, patients used concomitant analgesics as needed (which included opiates, acetaminophen, NSAIDs, and tricyclic antidepressants)2,4

In a third study, LIDODERM (lidocaine patch 5%) reduced the PHN pain qualities (NPS 10) described by patients (P=0.043)5,d

Pain qualities: Hot. Cold. Itchy. Intense. Sharp. Dull. Sensitive. Deep. Unpleasant. Surface pain.

a A randomized, double-blind, placebo-controlled, 4-way crossover trial (N=35) assessed safety and efficacy of LIDODERM. Patients were allodynic with a mean age of 75 years and mean PHN duration of 48 months. Pain intensity was measured with a horizontal 100-mm Visual Analogue Scale: 0=no pain and 100=worst pain imaginable. Measurements were recorded before patch application, at 30 minutes, and at hours 1, 2, 4, 6, 9, and 12. Least-squares means were used as the best unbiased estimate of the patients’ mean values.

b Results of enriched-enrollment studies can’t be generalized to the entire population; subjects in such studies may be able to distinguish the active drug from placebo based on nontherapeutic features of the treatments.

c Demonstrated over 14 days in a post hoc analysis of a randomized, enriched-enrollment, double-blind, placebo-controlled, crossover trial. Patients enrolled in the study had been using LIDODERM for ≥1 month (ie, enriched enrollment);mean age of 77.4 years andmean PHN duration of 7.3 years. Pain relief wasmeasured using a 6-itemverbal scale: 0 (worse), 1 (no relief), 2 (slight relief), 3 (moderate relief), 4 (a lot of relief), and 5 (complete relief). Patients exited the study if their verbal pain relief rating decreased >2 categories for any 2 consecutive days from baseline.

d Subanalysis of 96 patients from a 3-week placebo patch–controlled trial (N=150): LIDODERM patch, n=67; placebo patch, n=29. Patients assessed the severity of each pain quality using the Neuropathic Pain Scale (NPS) 0-10 scale, where 0=no pain and 10=worst imaginable intensity of themeasured pain quality; composite neuropathic pain scores (NPS 10) were obtained by totaling scores of individual pain qualities; composite NPS total scores ≥40 represent moderate to severe intensity of the measured pain quality.


Important Safety Information

LIDODERM® (lidocaine patch 5%) is indicated for relief of pain associated with post-herpetic neuralgia. Apply only to intact skin.

LIDODERM is contraindicated in patients with a history of sensitivity to local anesthetics (amide type) or any product component.

Even a used LIDODERM patch contains a large amount of lidocaine (at least 665 mg). The potential exists for a small child or pet to suffer serious adverse effects from chewing or ingesting a new or used LIDODERM patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of LIDODERM out of reach of children, pets, and others.

Excessive dosing, such as applying LIDODERM to larger areas or for longer than the recommended wearing time, could result in increased absorption of lidocaine and high blood concentrations leading to serious adverse effects.

Avoid contact of LIDODERM with the eye. If contact occurs, immediately wash the eye with water or saline and protect it until sensation returns. Avoid the use of external heat sources as this has not been evaluated and may increase plasma lidocaine levels.

Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally. LIDODERM should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. LIDODERM should also be used with caution in pregnant (including labor and delivery) or nursing mothers.

Allergic reactions, although rare, can occur.

During or immediately after LIDODERM treatment, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Other reactions may include dizziness, headache and nausea.

When LIDODERM is used concomitantly with local anesthetic products, the amount absorbed from all formulations must be considered.

Immediately discard used patches or remaining unused portions of cut patches in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.

Before prescribing LIDODERM, please refer to the full Prescribing Information.

References

  1. Lidoderm Prescribing Information. Chadds Ford, PA: Endo Pharmaceuticals Inc; 2010.
  2. Rowbotham MC, Davies PS, Verkempinck C, Galer BS. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain. 1996;65(1):39-44.
  3. Data on file, DOF-LD-02, Endo Pharmaceuticals Inc.
  4. Galer BS, Rowbotham MC, Perander J, Friedman E. Topical lidocaine patch relieves postherpetic neuralgia more effectively than a vehicle topical patch: results of an enriched enrollment study. Pain. 1999;80(3):533-538.
  5. Galer BS, Jensen MP, Ma T, Davies PS, Rowbotham MC. The lidocaine patch 5% effectively treats all neuropathic pain qualities: results of a randomized, double-blind, vehicle-controlled, 3-week efficacy study with use of the neuropathic pain scale. Clin J Pain. 2002;18(5):297-301.