Phase I/II Data Show that GSK’s Altabax (retapamulin ointment), 1% Decolonizes Staphylococcus aureus from Nasal Passages
- GlaxoSmithKline Planning Further Studies Investigating ALTABAX for Use in Staphylococcus aureus Nasal Decolonization -
LONDON, Oct. 26, 2008-New Phase I/II data show that ALTABAX® (retapamulin ointment), 1% provides highly superior efficacy to placebo in eradicating Staphylococcus aureus from the nasal passages of healthy volunteers. Eliminating carriage of this pathogen from the nose has shown potential in other studies in reducing the risk of developing S. aureus infections in patients who are nasal carriers. In patients with persistent nasal colonization of S. aureus, a three-day course of ALTABAX eradicated S. aureus in 93 percent of study participants versus 15 percent for placebo (p-value < 0.001) by day 12. The findings were presented on October 26, 2008, in Washington, DC, at the joint annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA).
“Staphylococcus aureus infections are a significant problem in the United States,” said Odin J. Naderer, Pharm D., Director, Clinical Pharmacology Discovery Medicine, GlaxoSmithKline. “We know that eradicating this pathogen from the nasal passages is important in preventing certain kinds of S. aureus infections, but there is a clear need for new treatment options due to rising bacterial resistance rates. We are very encouraged by these data showing ALTABAX can eradicate nasal carriage of this pathogen with a shorter course of therapy.”
Approximately 32 percent of the US population, or nearly 90 million people, carry the pathogen S. aureus in their nasal passages. Data from several studies suggest that nasal colonization of S. aureus increases a patient’s risk of developing certain types of S. aureus infections. Eliminating S. aureus from the nose of certain patients may lead to a decreased infection rate. This Phase I/II study demonstrates encouraging results suggesting that ALTABAX may provide a new option in the future to address the problem of S. aureus nasal colonization and the role colonization plays in infections with this organism. GlaxoSmithKline is planning further clinical trials investigating ALTABAX for nasal decolonization.
ALTABAX Eradicates Key Pathogen from Nasal Passages
In this phase I/II, double-blind study, healthy volunteers identified as persistent nasal carriers of S. aureus (n=43) were randomized to receive one of three treatment regimens: three days of ALTABAX ointment 1% followed by two days of placebo ointment; five days of ALTABAX ointment 1%; or five days of placebo ointment. Ointment was administered twice a day to each naris. Data shows that both the three-day and five-day regimens of ALTABAX were statistically superior to placebo in the eradication of S. aureus nasal carriage at day 12 (7 days post-treatment), with rates of nasal decolonization at 93 percent, 100 percent and 15 percent, respectively (p-value < 0.001).
A second evaluation was conducted 28 days after treatment ceased. Data showed that both three-day and five-day courses of ALTABAX were statistically superior to placebo at day 28 in maintaining decolonization of S. aureus from the nasal passages. The most common adverse events were headache, nasal discomfort and rhinorrhea and occurred at similar rates in the ALTABAX and placebo groups.
ALTABAX Information
ALTABAX is the first in a new class of topical antibacterials called pleuromutilins. ALTABAX is the only topical prescription antibacterial with a unique mode of action that works by disrupting protein synthesis in three ways. ALTABAX selectively inhibits bacterial protein synthesis by interacting at a site on the bacterial ribosome through a mechanism that is different than other antibacterials. In vitro, ALTABAX has shown a low potential for the development of resistance.
ALTABAX is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients) due to S. aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes. The most common drug-related adverse reaction was application site irritation (1.4% of patients). Currently, standard therapy of ALTABAX requires a five-day course of treatment.
About GlaxoSmithKline
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