Inhibitex Initiates Phase II Clinical Trial of FV-100 for the Treatment of Shingles
News May 12, 2009
Inhibitex, Inc. has announced that it has initiated a Phase II clinical trial with FV-100, its oral antiviral compound in clinical development for the treatment of herpes zoster (shingles).
The Phase II clinical trial is a well-controlled, double-blind study evaluating FV-100 against an active control (valacyclovir). Approximately 350 patients, aged 50 years and older, will be equally randomized to one of three treatment arms: 200 mg FV-100 administered once daily; 400 mg FV-100 administered once daily; and 1,000 mg valacyclovir administered three times per day.
In addition to further evaluating its safety, the objective of the trial is to evaluate the therapeutic benefit of FV-100 in reducing: the severity and duration of shingles-related acute pain; the incidence of post herpetic neuralgia (PHN); the time to lesion healing; and the use of concomitant pain medications.
“We are pleased to have commenced this well-powered Phase II trial, in which we will evaluate the potential of FV-100 to treat shingles as compared to the current standard of care,” stated Russell H. Plumb, president and chief executive officer of Inhibitex, Inc.
“We plan to ultimately utilize a total of 50-60 U.S. sites in the trial, and we believe this enthusiastic response from the clinical community reflects its recognition of the significant unmet medical needs of the increasing number of shingles patients.”
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