First New Topical Antibiotic Launched In UK For Nearly A Decade

Main Category: Dermatology
Also Included In: MRSA / Drug Resistance;  Regulatory Affairs / Drug Approvals
Article Date: 25 Feb 2008 - 4:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

ALTARGO(R) (retapamulin ointment, 1%), the first new topical antibiotic in nearly 10 years, is launched in the UK. The treatment is effective against localised impetigo,1 a contagious skin infection common in children and people who play contact sports or live in close vicinity to others.2,3

ALTARGO works fast; a five day course of treatment is as effective at treating localised impetigo as a seven day course of Fucidin® (fucidic acid),4 currently the most commonly used topical antibiotic in general practice. The ointment is also convenient; patients only have to apply the cream twice a day (BD) rather than three times (TDS),4 therefore removing their inconvenient midday dose4 - useful for adults with busy lifestyles or parents who would need to administer a lunchtime dose to their children.

Dr Jonathan Geldard, a GP from Essex with an interest in dermatology, commented,

"I see around five patients a month with impetigo. In an area where current treatment options are limited, it's great to finally have another option for my patients, especially one that's as efficacious with a shorter dosing regime. Impetigo is an unsightly, often embarrassing condition and the sooner the infection is cleared the better."

ALTARGO is the first in a new class of antibacterials called pleuromutilins which have a distinct mode of action. By attacking bacteria in four different ways, the potential for cross-resistance with other antibacterial classes currently used in general practice is reduced.5,6 Resistance to fucidic acid is an increasing problem in the UK, with particularly high levels in dermatology patients (up to 50%).7-12 Therefore, the availability of ALTARGO offers GPs an alternative treatment option, allowing fucidic acid to be preserved for systemic use in more serious conditions such as Staphylococcal bone infections. In these cases the development and impact of resistant bacterial strains can be far more significant.

Dr Robin Graham-Brown, Consultant and Honorary Senior Lecturer in Dermatology at the Leicester Royal Infirmary, commented, "Resistance to antibiotics is an increasing problem in the UK. Around one in three patients become resistant to topical antibiotics so we continually have to look for alternative treatments. The availability of a new topical antibiotic is therefore going to be greatly welcomed in the medical community."

Impetigo is the third most common skin infection in children after eczema and warts.2 It can also affect people who play contact sports, live in close vicinity to others or who have reduced immune defences, and recurrent infections are likely.13 If left untreated, impetigo can spread to other areas of the body and cause boils, abscesses and even toxic shock.13

Impetigo understandably causes a great deal of anxiety and embarrassment. Patients, especially worried parents, actively seek out information about the condition which is why it's important for GPs to be up to date on the latest treatments and are able to offer their patients an effective and convenient treatment regime that fits in with their lifestyles.

Healthcare professionals can request samples of ALTARGO by visiting http://www.livemedtalk.co.uk.

About ALTARGO®

- ALTARGO is licensed for the treatment of superficial skin infections such as localised impetigo and infected small lacerations, abrasions, or sutured wounds12

- An extensive clinical trial programme for ALTARGO has involved over 3,000 patients.1,4 In patients with localized impetigo, ALTARGO was more effective than placebo and at least as effective as fucidic acid,1,4 currently the most commonly used treatment in general practice

- ALTARGO does not demonstrate target specific cross-resistance with other classes of antibacterial agents and no development of resistance was observed during treatment with ALTARGO in the clinical study programme1,14

- The basic NHS cost for 1x 5g tube of ALTARGO is £7.8915

- The Summary of Product Characteristics (SPC) is available at http://www.medicines.org.uk

About pleuromutilins

- Pleuromutilins are a class of antibacterials that are potent and highly selective inhibitors of the bacterial protein synthesis machinery and, because of their unique mode of action, they possess excellent in vitro activity against bacteria that have become resistant to other classes of antibiotics1,5

- ALTARGO is the first pleuromutilin antibacterial to receive regulatory authorisation for use in humans

About impetigo

- Impetigo is a bacterial skin infection characterised by itchy blisters, usually on the face or hands16

- Impetigo is common, affecting over 230,000 children in the UK.17,18 It is the third most prevalent skin condition in children after eczema and warts2

- Impetigo can also affect people who play contact sports, live in close vicinity to others or who have reduced immune defences, and recurrent infections are likely13

- Impetigo is very contagious, with infection spread by direct skin to skin contact. If left untreated, impetigo can spread to other areas of the body, cause boils, abscesses and even toxic shock13

• For further information, please see the accompanying fact sheet - '10 things you might not know about impetigo'

About GlaxoSmithKline (GSK) and anti-infectives

- GSK has an established heritage in the development of novel anti-infectives to meet clinical needs

- GSK is committed to the discovery, development and commercialisation of innovative, potent antibacterials. Our approach includes in-house research using leading technologies, as well as actively seeking in-licensing opportunities and partnerships

- GSK, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Additional information about GSK can be found online at http://www.gsk.com

References

1. Oranje AP, Chosidow O et al. Topical Retapamulin Ointment, 1%, versus Sodium Fusidate Ointment, 2%, for Impetigo: A Randomized, Observer-Blinded, Noninferiority Study. Dermatology 2007; 215: 331��"340

2. Sladden M & Johnston M. Common skin infections in children. BMJ 2004; 329: 95-9

3. Playe SJ. Infections in Sports: CA-MRSA, herpes, impetigo, and more. Emergency Medicine News 2006; 28(7): 14

4. European Medicines Agency. European Public Assessment Report (EPAR): ALTARGO® 2007. Available from: http://www.emea.europa.eu [accessed February 2008]

5. Yan et al. Biochemical Characterization of the Interactions of the Novel Pleuromutilin Derivative Retapamuilin with Bacterial RIbosomes. Antimicrobial Agents and Chemotherapy. Nov 2006: 3875-81

6. ALTARGO® Summary of Product Characteristics (SPC). GlaxoSmithKline (GSK) 2007

7. Shah M & Monhanraj M. High levels of fusidic acid-resistance Staphlococcus aureus in dermatology patients. British Journal of Dermatology 2003; 148: 1018-20

8. Koning S, van Suijlekom-Smit LWA et alBMJ 2001; 324: 203-6

9. Andrews J, Ashby J et al. A comparison of antimicrobial resistance rates in Gram-positive pathogens isolated in the UK from October 1996 to January 1997 and October 1997 to January 1998. J Antimicrob Chemother 2000; 45: 285-93

10. Brown EM & Thomas P. Fusidic acid resistance in Staphylococcus aureus isolates. Lancet 2002; 359 (in press)

11. Rortveit S & Rortveit G. Impetigo in epidemic and nonepidemic phases: an incidence study over 41⁄2 years in a general population. Br J Dermatol 2007; 157: 100-5

12. Afset JE & Maeland JA. Susceptibility of skin and soft-tissue isolates of Staphylococcus aureus and Streptococcus pyogenes to topical antibiotics: indications of clonal spread of fusidic acid-resistant Staphylococcus aureus. Scand J Infect Dis 2003; 35: 84-9

13. National Library for Health. CKS: Impetigo - in depth [online]. Available here.[accessed February 2008]

14. Gentry DR, Rittenhouse SF et al. Stepwise exposure of Staphylococcus aureus to Pleuromutilins is associated with stepwise acquisition of mutations in rplC and minimally affects susceptibility to retapamulin. Antimicrobial agents and chemotherapy 2007; 51(6): 2048-52

15. ALTARGO® Prescribing Information (PI). GlaxoSmithKline (GSK) 2007

16. British Association of Dermatologists. Impetigo patient information leaflet 2004. Available from here. [accessed February 2008]

17. Royal College of General Practitioners, the Office of Population Censuses and Surveys and the Department of Health. Morbidity statistics from general practice: Fourth national study 1991-1992. 1995. Available from here. [accessed February 2008]

18. Office for National Statistics. Key population and vital statistics: Population and vital statistics by area of usual residence in the United Kingdom. 2005. Available from here.[accessed February 2008]

GlaxoSmithKline