Efficacy and tolerability of a 5% lidocaine medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study

ABSTRACTObjective: Evaluation of long-term efficacy and safety of the 5% lidocaine medicated plaster for neuropathic pain symptoms in patients with post-herpetic neuralgia (PHN).Materials and methods: Design – a 12-month, open-label, phase III study with an open-label extension conducted at 34 outpatient clinics in 12 European countries. Patients – aged ≥50 years, newly recruited (average pain intensity ≥4) or pre-treated with the 5% lidocaine medicated plaster in a previous study. Interventions – application of up to three 5% lidocaine medicated plasters dependent upon size of the painful area for up to 12 hours per day. Outcome measures – efficacy measures included patients’ recall of pain relief and pain intensity in the previous week. Adverse events (AEs) were also reported.Results: 249 patients participated in the 12-month study, 247 were analysed (full analysis set, FAS). Newly recruited patients had a mean average pain intensity (11-point numerical rating scale [NRS]) of 5.9 ± 1.4 at baseline, whic...