Grunenthal’s Versatis plaster relieves pain as effectively as oral treatment with Pfizer’s Lyrica but with fewer side-effects, according to results presented at the 12th World Congress on Pain in Glasgow.
This first-ever study to directly compare topical and systemic treatments in neuropathic pain goes some way to resolving questions about Versatis (5% lidocaine medicated plaster) raised after its European launch last year. The results were reported publicly for the first time in Glasgow, but last week the study inspired the Scottish Medicines Consortium to reverse its previous decision and recommend Versatis for restricted use on the National Health Service.
The study included over 300 European patients with post-herpetic neuralgia (PHN; post-shingles pain) or diabetic polyneuropathy (DPN; pain caused by diabetic nerve damage). At the end of the initial four-week head-to-head phase, response rates were similar in the two treatment groups, 65.3% for Versatis versus 62% for Lyrica (pregabalin). Although the study was not designed to show superiority of one drug over the other, there was some evidence of greater pain relief with Versatis in patients with PHN (62.2% versus 46.5% for Lyrica).
Overall, there were significantly fewer adverse events in the Versatis group (18.7% versus 46.4% with Lyrica). Patients receiving Versatis also experienced significantly fewer drug-related adverse events (5.8% versus 41.2%) and fewer patients on the Grunenthal drug withdrew from the study because of adverse drug reactions (5.8% versus 25.5%).
Other data presented in Glasgow suggest that Versatis continues to be effective and well tolerated in long-term treatment. Pain relief was maintained two years after start of treatment in the 62 patients included in the extension phase of an ongoing study. Drug-related adverse events (mainly related to administration site problems) were reported in 12.9% of patients who received at least one Versatis plaster during the study.
Both Versatis and Lyrica are currently licensed for PHN but not for DPN. Versatis’ European launch began early in 2007, but the plaster has been available in the USA since 1999, where it is also licensed for PHN and is marketed by Endo Pharmaceuticals as Lidoderm.
