ContraVir Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to begin a Phase III trial of its lead drug candidate, FV-100, for the prevention of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN).

FV-100 is a fast acting, low dose, once-daily oral antiviral agent under development to treat herpes zoster (shingles), an infection caused by the reactivation of varicella zoster virus.

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The agency has agreed to, with minor modifications, the company’s proposed clinical protocol, which is designed as a pivotal Phase III trial.

"We are encouraged by the added clarity and favorable position the FDA has taken regarding our clinical strategy for FV-100, and we look forward to initiating the Phase 3 trial in the second quarter 2015."

The company is exploring the potential of FV-100 to prevent the severe and long-lasting effects of this condition. Currently, there are no approved antiviral therapies to prevent PHN and it remains a major unmet medical need.

ContraVir chief executive officer James Sapirstein said: "We are encouraged by the added clarity and favorable position the FDA has taken regarding our clinical strategy for FV-100, and we look forward to initiating the Phase 3 trial in the second quarter 2015.

"The proposed plan for clinical development of FV-100, agreed to by the FDA, significantly shortens the development pathway for FV-100. This will save ContraVir considerable time and money."

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The company said that the new Phase III trial will build upon prior clinical results for FV-100, including Phase I trials as well as a large Phase II clinical trial in shingles patients, which showed excellent safety and tolerability for FV-100.

Apart from direct antiviral activity, FV-100 has showed the potential to reduce the incidence of debilitating shingles-associated pain, known as post-herpetic neuralgia (PHN).

The company is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir DF (Viread).

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