LONDON, August 21 The medicated pain relief plaster,(Versatis) is now approved by the Scottish Medicines Consortium (SMC) forrestricted use within NHS Scotland for patients suffering pain followingshingles(1) http://www.scottishmedicines.org.uk/smc/5850.html. This reversalof the previous SMC decision (issued in February 2007) for Versatis (5%lidocaine medicated plaster) is based on significant new clinical andcost-effectiveness comparative data and brings prescribing availability ofthe treatment in line with England and Wales. These new data on Versatis willbe presented for the first time at the International Association for theStudy of Pain (IASP) Congress in Glasgow (17-22 August 2008).
The pain that persists for more than three months after the onset of theshingles rash is called Post-herpetic Neuralgia (PHN) (2). PHN affectsapproximately 200,000 people in the UK(3). PHN can be described as anincessant burning, stabbing or shooting pain. The pain can start severalweeks or even months after the shingles rash has gone and can continue forweeks, months or years(4).
Licensed in the UK in 2007, Versatis offers sustained pain reliefassociated with PHN(5). Versatis is an innovative combination of localanalgesic lidocaine and a soft hydrogel plaster. Application of the plasterto the skin releases an appropriate level of lidocaine into the skin toimpair the transfer of signals which would be associated with the perceptionof pain.
Based on clinical trial data, Versatis is used as a continuous once-daily12 hours on/12 hours off application schedule for 2-4 weeks and providesrapid and continuous pain relief from 30 minutes after application(6).
Dr Michael Serpell, Consultant and Senior Lecturer in Anaesthesia,Glasgow says: "The new recommendation from the SMC is to be welcomed. Newdata supporting the role of Versatis in post-herpetic neuralgia will furtherestablish that such a novel, non-systemic treatment approach offerssignificant benefits in the older patient group who suffer co-morbidities andconsequential polypharmacy".
Heather Wallace, Chairman of Pain Concern commented: "The SMC is to becongratulated on its revised decision for Versatis. They've taken a huge stepforward in extending options for pain relief for people living withneuropathic pain. This decision will alleviate a lot of suffering".
The risk of developing PHN increases with age - it is most common inpeople aged over 50. About half of shingles cases affecting people of the ageof 65 will cause PHN(7,8).
Versatis 5% medicated plaster. Refer to the Summary of ProductCharacteristics (SPC) for full details on side effects, warnings andcontra-indications before prescribing. Presentation: Versatis is a medicatedplaster (10cm x 14cm) containing 700 mg (5% w/w) of lidocaine in an aqueousadhesive base. Indication: Treatment of neuropathic pain associated withprevious herpes zoster infection (post-herpetic neuralgia, PHN). Dosage andmethod of administration: Adults and elderly patients: Use up to threeplasters for up to 12 hours, followed by at least a 12 hour plaster-freeinterval. Cover painful area once daily. Apply the plaster to intact, dry,non-irritated skin (after healing of the shingles). Remove hairs in affectedarea with scissors (do not shave). Remove the plaster from sachet and itssurface liner before applying immediately to the skin. Plasters may be cut tosize. Patients under 18 years: Not recommended. Contra-indications:Hypersensitivity to active substance, any excipients, or local anaestheticsof 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 membranesor the eyes. Plasters contain propylene glycol which may cause skinirritation, methyl parahydroxybenzoate a