Altabax (retapamulin ointment) is a first-in-class topical antibacterial for the treatment of impetigo - a superficial skin infection that most commonly affects young children with still-developing immune systems as well as people who play close contact sports such as rugby, football and wrestling.
The drug has been cleared for twice daily use for up to five days in patients over nine months old and will make treating infants easier than with other topical antibacterials that may need to be used as often as three times a day for up to 12 days.
The treatment was approved late last week by the US Food and Drug Administration (FDA) and a spokesperson for GSK told DrugResearcher.com that they hope to gain European approval shortly.
If approved, the treatment will be sold under the Altargo tradename in the EU - this looks likely as GSK received positive opinion from the EUs Committee for Medicinal Products for Human Use (CHMP) last month.
Impetigo is caused by strains of Staphylococcus aureus ( S.aureus ) or Streptococcus pyogenes ( S.pyogenes ) and is characterised by pimple-like lesions that are surrounded by red, inflamed skin.
The lesions fill with pus that breaks down over a few days to form a thick crust.
" The introduction of Altabax comes at a time when antibiotic resistance is at an increasingly high level," said Dr Stan Block, President of Kentucky Pediatric and Adult Research.
"In vitro, this new topical antibiotic has shown a low potential for the development of resistance, possibly because it works in a unique manner compared to other antibiotics."
Altabax binds to the 50S sub-unit of the bacterial ribosome, inhibiting the bacteria's ability to synthesise proteins, effectively leading to the bacteria's death.
This ribosomal interaction is unique to the pleuromutilin class of antibacterials and the company claims that the new treatment has so far shown no target-specific cross resistance to other established classes of antibacterials.
While Altabax is the first example of a pleuromutilin developed for human use, several examples, tiamulin and valnemulin, of this class have been used in veterinary practice to control and treat serious infections in swine.
A study published in Antimicrobial Agents and Chemotherapy in July 2006 claimed that retapamulin appeared to be eight times more potent that tiamulin.
Antibiotics were first introduced in the 1940s and were considered to be miracle drugs by many health authorities.
However, over-prescription and improper use has led to the spread of antibiotic resistance and reopened the door for increased R&D spending by drug companies that had previously seen the market as unappealing because it as swamped with generics and the development of new drugs was often viewed as long and arduous.
This had led to many of the biggest drug firms, including Eli Lilly, Wyeth and Roche, closing down plants and R&D programmes, although there has been a resurgence of interest in the feld of late.
In recent months, new antibiotics from the likes of Wyeth (Tygacil; tigecycline) Pfizer (Zyvox; linezolid) and Novartis/Cubist (Cubicin; daptomycin) have added to a small but growing arsenal of drugs against resistant bacterial infections.