Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Famciclovir · 6 trials · 6 indications
Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
PK parameter; penciclovir is the active metabolite of famciclovir.
PK parameter; penciclovir is the active metabolite of famciclovir.
PK parameter; penciclovir is the active metabolite of famciclovir.
PK parameter; penciclovir is the active metabolite of famciclovir.
PK parameter; penciclovir is the active metabolite of famciclovir
A patient with multiple AEs within the primary system organ class is counted only once in total row.
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Participants with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities. Laboratory values were assessed according to the National Cancer Institute- Common terminology criteria for Adverse Events (NCI-CTCAE). Hematology, Urinalysis and clinical chemistry were reported .
Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
Measured by Cmax - The maximum plasma concentration of study medication
Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.
Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).
| Arm | Type | Description |
|---|---|---|
| Famciclovir | EXPERIMENTAL | Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. |
| Valacyclovir | ACTIVE_COMPARATOR | Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir. |
| Famciclovir, pediatric oral formulation | EXPERIMENTAL | single-arm |
| Name | Type | Description |
|---|---|---|
| Famciclovir | DRUG | Famciclovir 500 mg tablet |
| Valacyclovir | DRUG | Valacyclovir 500 mg capsule |
| Placebo matching famciclovir | DRUG | Famciclovir placebo, matching in size, color and forms of famciclovir tablet. |
| Placebo matching valacyclovir | DRUG | Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule. |
Inclusion Criteria: * At least 18 years old * History of at least 4 recurrences of genital herpes in the preceding 12 months * Lesions located on the external genitalia or anogenital region * Willing to discontinue suppressive treatment * Documented positive herpes simplex virus (HSV) * General goo...
Famciclovir is an investigational small molecule being studied for the treatment of recurrent genital herpes, herpes simplex, herpes labialis, genital herpes, and chickenpox. It is in Phase 3 clinical development for these infectious disease indications.
Famciclovir is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in pediatric and adult patient populations.
Famciclovir is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 3 trials have been completed to assess its use in herpes-related infections.
Famciclovir has been studied in several completed clinical trials, including NCT00098046 in children with chickenpox, NCT00098059 in children with herpes simplex, and NCT00306787 comparing a 1-day famciclovir regimen to a 3-day valacyclovir regimen in adults with recurrent genital herpes.
No, Famciclovir is not the same as valacyclovir. They are separate antiviral drugs. In one clinical trial, NCT00306787, a 1-day treatment with famciclovir was directly compared to a 3-day treatment with valacyclovir in adults with recurrent genital herpes.
Yes, Famciclovir has been studied in pediatric populations. Completed Phase 3 trials evaluated an oral pediatric formulation in children aged 1 to 12 years with chickenpox or herpes simplex infection, and a Phase 2 trial assessed the drug in infants aged 1 month to less than 12 months.