Shingles Pain Treatment Will Benefit More Patients

    LONDON, August 21 /EMWNews/ -- 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).



    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 (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:



    Janis Troup/Debra Lord at Right Angle Communications: Tel:

+44(0)20-8846-3170 or [email protected] or

[email protected]



    Grunenthal medical information department: Tel: +44(0)870-351-8960

(follow options).