Scottish Medicines Consortium Recommends Versatis(R) In Post-Herpetic Neuralgia

Main Category: Pain / Anesthetics
Article Date: 15 Aug 2008 - 1:00 PDT

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The SMC (Scottish Medicines Consortium) now recommends Versatis (5% lidocaine medicated plaster) for restricted use within NHS Scotland for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN)1. The SMC advice page can be found here. This reversal of the previous SMC decision (issued in February 2007) is based on the availability of significant new clinical and cost-effectiveness comparative data. These data will be presented for the first time at the International Association for the Study of Pain (IASP) Congress (17-22 August 2008).

Licensed in the UK January 2007, Versatis offers sustained pain relief associated with previous post-herpetic neuralgia, PHN2, Versatis is an innovative combination of local analgesic lidocaine and a soft hydrogel plaster. Application of the plaster to the skin releases an appropriate level of lidocaine into the skin to block abnormal sodium channels and impair the transfer of signals which would be associated with the perception of pain.

Based on clinical trial data, the Versatis SPC recommends a continuous once-daily 12 hours on/12 hours off application schedule for 2-4 weeks and provides rapid and continuous pain relief 30 minutes after application3.

Dr Michael Serpell, Consultant and Senior Lecturer in Anaesthesia, Glasgow says: "The new recommendation from the SMC is to be welcomed. New data supporting the role of Versatis in post-herpetic neuralgia will further establish that such a novel, non-systemic treatment approach offers significant benefits in the older patient group who suffer co-morbidities and consequential polypharmacy".

Heather Wallace, Chairman of Pain Concern commented: "The SMC is to be congratulated on its revised decision for Versatis. They've taken a huge step forward in extending options for pain relief for people living with neuropathic pain. This decision will alleviate a lot of suffering".

Further new Versatis data will be presented at the IASP Congress on the long term efficacy and tolerability in post-herpetic neuralgia

References:

1. Scottish Medicines Consortium, NHS Scotland, website: http://www.scottishmedicines.org.uk/smc/5850.html
2. Baron R et al. Abstract presented at the Congress of the European Federation of IASP Chapter, Istanbul 2006
3. Versatis Summary of Product Characteristics

Prescribing Information

Versatis 5% medicated plaster. Refer to the Summary of Product Characteristics (SPC) for full details on side effects, warnings and contra-indications before prescribing. Presentation: Versatis is a medicated plaster (10cm x 14cm) containing 700 mg (5% w/w) of lidocaine in an aqueous adhesive base. Indication: Treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN). Dosage and method of administration: Adults and elderly patients: Use up to three plasters for up to 12 hours, followed by at least a 12 hour plaster-free interval. Cover painful area once daily. Apply the plaster to intact, dry, non-irritated skin (after healing of the shingles). Remove hairs in affected area with scissors (do not shave). Remove the plaster from sachet and its surface liner before applying immediately to the skin. Plasters may be cut to size. Patients under 18 years: Not recommended. Contra-indications: Hypersensitivity to active substance, any excipients, or local anaesthetics of amide type (e.g. bupivacaine, etidocaine, mepivacaine and prilocaine). Warnings and precautions: Do not apply to inflamed or injured skin (e.g. active herpes zoster lesions, atopic dermatitis or wounds), mucous membranes or the eyes. Plasters contain propylene glycol which may cause skin irritation, methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions. Use with caution in patients with severe cardiac impairment, severe renal impairment or severe hepatic impairment. Interactions: No clinically relevant interactions have been observed in clinical studies. Absorption of lidocaine from the skin is low. Use with caution in patients receiving Class I antiarrhythmic drugs (e.g. tocainide, mexiletine) or other local anaesthetics. Pregnancy and lactation: Do not use during pregnancy or breast-feeding. Undesirable effects: Very common (³10%): administration site reactions (e.g. erythema, rash, pruritus, burning). Uncommon (>0.1%-£1%): skin injury, skin lesion. Very rare (<0.01%) but potentially serious: anaphylaxis, hypersensitivity. Adverse reactions were predominantly of mild and moderate intensity. Systemic adverse reactions are unlikely. See SPC for full details. Overdose: Unlikely. If suspected, remove plasters, provide supportive treatment (see SPC). Legal classification: POM. Marketing Authorisation number, pack sizes and basic NHS cost: PL 21727/0016, 30 plasters (£ 72.40). Marketing Authorisation Holder: Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, UK. Date of text: June 2008. V0138

Information about adverse event reporting can be found at: http://www.yellowcard.gov.uk

Grunenthal Ltd

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