Drugs Xagena
The Food and Drug Administration ( FDA ) has approved Zyclara cream for the treatment of external genital and perianal warts ( EGW ) in patients 12 years of age and older.
Zyclara cream’s clinical studies have demonstrated that using its once-daily treatment regimen, for up to eight weeks, safely and effectively clears genital warts.
In addition, data have shown that of those patients who achieved complete clearance, only a small number experienced a recurrence of their wart(s) 12 weeks after treatment.
Most approved topical prescription treatments currently available to treat external genital and perianal warts are associated with lengthy treatment regimens, which may impact patient compliance.
Zyclara cream was developed to meet the need for a shorter treatment regimen, while maintaining the efficacy ( both initial and sustained clearance ) that Imiquimod has delivered for more than a decade.
Two phase III double-blind, placebo-controlled efficacy and safety studies of Imiquimod 3.75% cream have evaluated complete clearance of all warts - defined as clearance of baseline and emergent warts - across several anatomical locations.
In an intent-to-treat analysis of all participants who began the study, regardless of whether they completed it, complete clearance of all warts was achieved in 28.3% of patients on Imiquimod 3.75% cream, compared to 9.4% on placebo cream.
Additionally, efficacy was greater in females than males for all primary and secondary efficacy measurements, and 37% of females on the 3.75% formulation achieved complete clearance compared to 19% of males.
In subjects with complete clearance only 15% treated with Imiquimod 3.75% cream experienced a recurrence of their warts within 12 weeks.
Genital warts are caused by the human papillomavirus. Zyclara cream works by increasing the immune response. Zyclara cream has shown promising results in preventing genital wart recurrence for twelve weeks in the majority of patients who cleared during the clinical study.
The most frequently reported adverse events were local skin and application site reactions. Overall, less than 1% of subjects treated with Zyclara cream discontinued due to local skin / application site reactions. Local skin reactions included redness, swelling, sores or blisters, and weeping. ( Xagena )
Fonte: Graceway Pharmaceutical, 2011
XagenaMedicine_2011
