Zyclara (imiquimod cream, Graceway Pharmaceuticals) has been approved for the treatment of external genital and perianal warts in patients ≥12 years of age. This approval was based on data from two Phase 3 double-blind, placebo-controlled efficacy and safety studies of Zyclara cream evaluating the complete clearance of all warts across several anatomical locations. In an intent-to-treat analysis of all enrolled patients, complete clearance of all warts was achieved in 28.3% of patients treated wtih Zyclara cream, compared with 9.4% in those who received placebo cream. In patients with complete clearance, only 15% treated with Zyclara cream experienced a recurrence of their warts within 12 weeks.
Zyclara is already approved for the treatment of actinic keratoses of the face or balding scalp in immunocompetent patients.
For more information call (800) 328-0255 or visit www.zyclaracream.com.