FDA has cleared Graceway® Pharmaceuticals’ once-daily Zyclara® 3.75% Cream (imiquimod) for the topical treatment of external genital and perianal warts in patients aged 12 years and over. Approval was based on data from two Phase III placebo-controlled studies that showed that on an intent-to-treat basis, 28.3% of patients using imiquimod achieved complete clearance of all warts, compared with 9.4% of patients using a placebo cream.
Efficacy was greater in females than males for all primary and secondary efficacy measures, the firm notes. 37% of all females using imiquimod cream achieved complete wart clearance, compared with 19% of males. The overall recurrence rate among all imiquimod cohort subjects who achieved complete clearance was 15% within 12 weeks
“Many of the currently approved topical treatments for genital warts are not ideal due to lengthy and confusing dosing regimens,” comments Jefferson J. Gregory, chairman and CEO at Graceway. “Our vision for Zyclara Cream is to improve patient experience by offering a more intuitive dosing regimen (once daily treatment for up to eight weeks) with the goal of improving patient compliance.”