Graceway Pharmaceuticals, LLC Release: New Data Demonstrate Zyclara(TM) Imiquimod 3.75% Superior to Placebo for Treatment of External Genital Warts (EGW)

BRISTOL, Tenn.--(BUSINESS WIRE)--Results from a Phase III program evaluating imiquimod 3.75% and 2.5% creams for the treatment of EGW, applied once daily for up to 8 weeks, demonstrated that both were well-tolerated and more efficacious than placebo, according to data presented at the annual Human Papillomavirus (HPV) Conference in Montreal, July 3 – 8. Investigators found that efficacy was greatest for imiquimod 3.75% with an enhanced safety profile. The data were included in a New Drug Application (NDA) accepted for review by the U.S. Food and Drug Administration for an eight-week treatment regimen of imiquimod 3.75% for the treatment of EGW.