Altabax (retapamulin)
Company: Glaxo
Approval Status: Approved April 2007
Treatment for: impetigo due to Staphylococcus aureus or Streptococcus pyogenes
Areas: Dermatology/Plastic Surgery; Immunology/Infectious Diseases; Pediatrics/Neonatology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
Altabax is specifically 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 aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.
Altabax is supplied as a gel in 5, 10, and 15 gram tubes for topical administration. The recommended initial dose of the drug is a thin layer over the infected area up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) twice daily for 5 days.
Clinical Results
FDA ApprovalFDA approval of Altabax was based on the results of a double-blind, randomized, multi-center, parallel group, comparison trial. This study enrolled 210 adult and pediatric subjects, aged 9 months of age and older, with impetigo up to 100 cm2 in total area (up to 10 lesions) or a total body surface area not exceeding 2%. Subjects were randomized 2:1 to receive Altabax or placebo for five days. Success was defined as the absence of treated lesions, or treated lesions had become dry without crusts with or without erythema compared to baseline, or had improved (defined as a decline in the size of the affected area, number of lesions or both) such that no further antimicrobial therapy was required. The intent-to-treat clinical (ITTC) population consisted of all randomized subjects who took at least 1 dose of Altabax. The clinical per protocol (PPC) population included all ITTC patients who satisfied the inclusion/exclusion criteria and subsequently adhered to the protocol. The intent-to-treat bacteriological (ITTB) population consisted of all randomized patients who took at least one dose of study medication and had a pathogen identified at study entry. The bacteriological per protocol (PPB) population included all ITTB patients who satisfied the inclusion/exclusion criteria and subsequently adhered to the protocol. At the end of therapy, two days after treatment , the success rates in the Altabax group were as follows: PPC (89.5%), ITTC (85.6%), PPB (89.7%), ITTB (88.6%) versus 53.2%, 52.1%, 50.0% and 49.1%, respectively, for placebo. At the treatment follow-up (9 days after therapy) success rates were as follows: PPC (82.4%), ITTC (75.5%), PPB (84.3%) and ITTB (79.8%) versus 43.1%, 39.4%, 37.5% and 33.3%, respectively, for placebo. At the end of therapy, the success rates for the subjects infected with Staphylococcus aureus was 89.8% versus 52.1% for placebo. The success rates for the subjects infected with Streptococcus pyogenes was 90.6% versus 42.9% with placebo. At the 9 day follow-up the success rates for the subjects infected with Staphylococcus aureus was 84.5% versus 43.2% for placebo. The success rates for the subjects infected with Streptococcus pyogenes was 90.6% versus 33.3% for placebo.
Ongoing Study Commitments
- GlaxoSmithKline has agreed to a deferred pediatric study under PREA for the treatment of impetigo in pediatric patients ages 2
months to 9 months.
Final Report Submission: December 31, 2007
Side Effects
Adverse events associated with the use of Altabax in adults may include, but are not limited to, the following:- Headache
- Application Site Reaction
- Diarrhea
- Nausea
- Nasopharyngitis.
Adverse events associated with the use of Altabax in pediatrics may include, but are not limited to, the following:
- Application site pruritus
- Diarrhea
- Nasopharyngitis
- Pruritus
- Eczema
- Headache
- Pyrexia
Mechanism of Action
Altabax is a bacterial protein synthesis inhibitor belonging to a class of compounds called pleuromutilins. These compounds act by inhibiting the initiation of protein synthesis at the level of bacterial 50S ribosome. This binding site involves ribosomal protein L3 and is in the region of the ribosomal P site and peptidyl transferase center. By virtue of binding to this site, pleuromutilins inhibit peptidyl transfer, block P-site interactions, and prevent the normal formation of active 50S ribosomal subunits.Literature References
Rittenhouse S, Singley C, Hoover J, Page R, Payne D Use of the surgical wound infection model to determine the efficacious dosing regimen of retapamulin, a novel topical antibiotic. Antimicrobial agents and chemotherapy 2006 Nov;50(11):3886-8Free A, Roth E, Dalessandro M, Hiram J, Scangarella N, Shawar R, White S; SB275833/030 Study Group. Retapamulin ointment twice daily for 5 days vs oral cephalexin twice daily for 10 days for empiric treatment of secondarily infected traumatic lesions of the skin. Skinmed 2006 Sep-Oct;5(5):224-32.
Jones RN, Fritsche TR, Sader HS, Ross JE Activity of retapamulin (SB-275833), a novel pleuromutilin, against selected resistant gram-positive cocci. Antimicrobial agents and chemotherapy 2006 Jul;50(7):2583-6.
Pankuch GA, Lin G, Hoellman DB, Good CE, Jacobs MR, Appelbaum PC Activity of retapamulin against Streptococcus pyogenes and Staphylococcus aureus evaluated by agar dilution, microdilution, E-test, and disk diffusion methodologies. Antimicrobial agents and chemotherapy 2006 May;50(5):1727-30.
Additional Information
For additional information regarding Altabax or impetigo, please visit the Altabax web page.The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
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