LONDON, August 21 /PRNewswire/ — The medicated pain relief plaster, (Versatis) is now approved by the Scottish Medicines Consortium (SMC) for restricted use within NHS Scotland for patients suffering pain following shingles(1) http://www.scottishmedicines.org.uk/smc/5850.html. This reversal of the previous SMC decision (issued in February 2007) for Versatis (5% lidocaine medicated plaster) is based on significant new clinical and cost-effectiveness comparative data and brings prescribing availability of the treatment in line with England and Wales. These new data on Versatis will be presented for the first time at the International Association for the Study of Pain (IASP) Congress in Glasgow (17-22 August 2008).
The pain that persists for more than three months after the onset of the shingles rash is called Post-herpetic Neuralgia (PHN) (2). PHN affects approximately 200,000 people in the UK(3). PHN can be described as an incessant burning, stabbing or shooting pain. The pain can start several weeks or even months after the shingles rash has gone and can continue for weeks, months or years(4).
Licensed in the UK in 2007, Versatis offers sustained pain relief associated with PHN(5). 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 impair the transfer of signals which would be associated with the perception of pain.
Based on clinical trial data, Versatis is used as a continuous once-daily 12 hours on/12 hours off application schedule for 2-4 weeks and provides rapid 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. 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”.
The risk of developing PHN increases with age – it is most common in people aged over 50. About half of shingles cases affecting people of the age of 65 will cause PHN(7,8).
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 (greater than or equal to 10%): administration site reactions (e.g. erythema, rash, pruritus, burning). Uncommon (>0.1%-less than or equal to 1%): skin injury, skin lesion. Very rare (less than or equal to 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 (GBP 72.40). Marketing Authorisation Holder: Grunenthal 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/
Adverse events should also be reported to Grunenthal Ltd (telephone +44(0)870-351-8960) References: 1) Scottish Medicines Consortium, NHS Scotland, website: http://www.scottishmedicines.org.uk/smc/5850.html 2) Cunningham, A. and Dworkin, R. (2000) The Management of post-herpetic neuralgia. BMJ 321, 778-779 3) Shingles Support Society. Bowsher D. Treatment of post-herpetic neuralgia in the elderly. Available at: http://www.herpes.org.uk/shingles/index.html 4) Herpes Viruses Association. Available at: http://www.herpes.org.uk/ 5) Versatis Summary of Product Characteristics 6) Baron R et al. Abstract presented at the Congress of the European Federation of IASP Chapter, Istanbul 2006 7) Shingles Support Society. Bowsher D. Treatment of post-herpetic neuralgia in the elderly. Available at: http://www.herpes.org.uk/shingles/index.html 8) http://cks.library.nhs.uk/patient_information_leaflet/neuralgia For further information, please contact:
Grunenthal medical information department: Tel: +44(0)870-351-8960 (follow options).
CONTACT: For further information, please contact: Janis Troup/DebraLord at Right Angle Communications: Tel: +44(0)20-8846-3170 [email protected] or [email protected]; Grunenthalmedical information department: Tel: +44(0)870-351-8960 (follow options).