Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
retapamulin · 2 trials · 2 indications
"Clinical Success" at follow-up was defined as "Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of "0". Clinical response at follow-up was classified as "Clinical Failure" for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items.
Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.
Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.
Cmax is the peak serum concentration. Low value was not calculable, and High value was 2.74 ng/mL.
Cmax is the peak serum concentration. Low value was not calculable, and high value was 2.74 ng/mL
Subjects who tested positive as persistent carriers of S. Aureus who on day 12 are negative and have been eradicated of S. Aureus.
| Arm | Type | Description |
|---|---|---|
| Retapamulin Ointment, 1% | EXPERIMENTAL | - |
| Placebo Ointment | PLACEBO_COMPARATOR | - |
| Treatment B | EXPERIMENTAL | 200mg BID retapamulin 5 days |
| Treatment C | PLACEBO_COMPARATOR | 200mg BID placebo 5 days |
| Treatment A | EXPERIMENTAL | 200mg BID retapamulin 3 days and placebo BID 2 days for a total of 5 days |
| Name | Type | Description |
|---|---|---|
| Retapamulin Ointment, 1% | DRUG | Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. |
| Placebo ointment | DRUG | Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. |
| retapamulin | DRUG | 200mg BID retapamulin 3 days |
| Placebo | DRUG | 200mg BID placebo 5 days |
Inclusion criteria: * subject is aged 2 months or older * subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion) * negative urine pregnancy test * subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3 * subjec...
Retapamulin is an antibacterial medicine studied for bacterial skin infections, including secondarily infected traumatic lesions. It has also been studied in healthy adults whose noses were colonized with Staphylococcus aureus. It is a topical small molecule antibacterial developed by GSK plc.
Retapamulin is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials of retapamulin, including the Phase 3 study in secondarily infected traumatic lesions and the Phase 2 study in healthy adults nasally colonized with Staphylococcus aureus.
Retapamulin is in Phase 2 development. One completed Phase 2 trial studied retapamulin ointment in healthy adults nasally colonized with Staphylococcus aureus. A separate Phase 3 trial in secondarily infected traumatic lesions has also been completed. Retapamulin is investigational and is not approved.
Retapamulin has been studied in two completed trials. NCT00684177 was a Phase 3, randomized, double-blind, placebo-controlled trial of retapamulin versus placebo in secondarily infected traumatic lesions, enrolling 508 participants across the United States, Argentina, Brazil, India, and South Africa. NCT00539994 was a Phase 2 trial in healthy adults nasally colonized with Staphylococcus aureus, enrolling 57 participants in the United States.
Yes. Retapamulin is also known as Retapamulin Ointment, 1%, and Retapamulin, 1%. These names refer to the same topical small molecule antibacterial developed by GSK plc for bacterial skin infections and related bacterial colonization studies.