Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Famvir
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 used to treat viral infections caused by herpes simplex virus, including chickenpox, genital herpes, herpes labialis, herpes simplex, and recurrent genital herpes. It is a small molecule antiviral developed by Novartis AG. Clinical trials have evaluated it in adults with recurrent genital herpes and in pediatric patients with herpes labialis or herpes simplex infection.
Famciclovir is developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored clinical trials of the drug in herpes simplex and herpes labialis infections, including studies in adolescents and infants.
Famciclovir has been studied in Phase 3 clinical trials. Two completed Phase 3 trials evaluated oral famciclovir in adults with recurrent genital herpes, including a comparison of 1-day famciclovir treatment versus 3-day valacyclovir treatment. The drug has also been tested in Phase 2 trials in pediatric populations.
Famciclovir has been evaluated in completed clinical trials including NCT00306787, a Phase 3 study of 1-day famciclovir versus 3-day valacyclovir in adults with recurrent genital herpes, and NCT00171990, a Phase 3 trial in adults with active recurrent genital herpes. Phase 2 trials NCT00878072 and NCT00448227 studied pediatric patients with herpes labialis and herpes simplex, respectively.
Famciclovir is an investigational drug that has been studied in Phase 3 clinical trials for herpes virus infections. The available information does not indicate that it has received FDA approval for these indications.