Monday 18 August 2008

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

�The SMC (Scottish Medicines Consortium) now recommends Versatis (5% lidocaine medicated stick on) for restricted use inside NHS Scotland for the treatment of neuropathic painful sensation associated with previous herpes zoster infection (post-herpetic neuralgia, PHN)1. The SMC advice page potty be establish here. This reversal of the previous SMC decision (issued in February 2007) is based on the availability of significant unexampled clinical and cost-effectiveness relative data. These data testament 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 annoyance relief associated with old post-herpetic neuralgy, PHN2, Versatis is an innovative combination of local analgesic xylocaine and a soft hydrogel plaster. Application of the plaster to the skin releases an appropriate level of xylocaine 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 turned application agenda for two dozen weeks and provides rapid and uninterrupted pain relief 30 transactions after application3.


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


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


Further modern Versatis data will be presented at the IASP Congress on the tenacious 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 inside information 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 xylocaine in an aqueous adhesive agent 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 60 minutes plaster-free interval. Cover irritating area at one time daily. Apply the plaster to entire, dry, non-irritated skin (later on healing of the zoster). Remove hairs in unnatural area with scissors (do not shave). Remove the plaster from sachet and its open 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, whatsoever excipients, or local anaesthetics of amide type (e.g. bupivacaine, etidocaine, mepivacaine and prilocaine). Warnings and precautions: Do non apply to inflamed or injured peel (e.g. active herpes zoster lesions, atopic dermatitis or wounds), mucous membranes or the eyes. Plasters contain propene glycol which may reason skin irritation, methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions. Use with caution in patients with severe cardiac impairment, severe renal deadening or severe hepatic harm. Interactions: No clinically relevant interactions have been ascertained in clinical studies. Absorption of lidocaine from the skin is low. Use with caution in patients receiving Class I antiarrhythmic drug drugs (e.g. tocainide, mexiletine) or other local anaesthetics. Pregnancy and lactation: Do not usage during pregnancy or breast feeding. Undesirable personal effects: Very common (�10%): administration site reactions (e.g. erythema, rash, pruritus, burning). Uncommon (>0.1%-�1%): skin injury, skin wound. Very rare (Overdose: Unlikely. If suspected, remove plasters, provide supportive treatment (see SPC). Legal classification: POM. Marketing Authorisation number, pack sizes and introductory NHS cost: PL 21727/0016, 30 plasters (� 72.40). Marketing Authorisation Holder: Gr�nenthal 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 pot be found at: hypertext transfer protocol://www.yellowcard.gov.uk

Grunenthal Ltd


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