Title: FDA submission
Affiliated institution: Bristol-Meyers Squibb/Gillette
Cited in: Prescription insert at vaniqa.com
Two randomized double-blind studies involving 594 female patients (393 treated with VANIQA, 201 with vehicle) treated twice daily for up to 24 weeks evaluated the efficacy of VANIQA in the reduction of unwanted facial hair in women. Women in the trial had a customary frequency of removal of facial hair two or more times per week. Physicians assessed the improvement or worsening from the baseline condition (Physician’s Global Assessment [PGA]), 48 hours after shaving, of all treated areas. Statistically significant improvement for VANIQA versus vehicle was seen in each of these studies for “marked improvement” or greater response (24-week time point; p•0.001). Marked improvement was seen consistently at 8 weeks after initiation of treatment and continued throughout the 24 weeks of treatment. Hair growth approached pretreatment levels within 8 weeks of treatment withdrawal. Approximately 32% of patients showed marked improvement or greater (protocol definition of clinical success) after 24 weeks of treatment with VANIQA, compared to 8% with the vehicle. Combined results of these two trials through 24 weeks are presented below.
Subgroup analyses appeared to suggest greater benefit for Whites than non-Whites (37% vs. 22% success, respectively; p=0.017). However, non-Whites, mostly Black subjects, did have significant treatment benefit with 22% graded as success on VANIQA compared to 5% on vehicle. About 12% of women in the clinical trials were postmenopausal. Significant improvement in PGA outcome versus vehicle was seen in postmenopausal women (38% compared to 0%, p•0.001). VANIQA statistically significantly reduced how bothered patients felt by their facial hair and by the time spent removing, treating, or concealing facial hair. These patient-observable differences were seen as early as 8 weeks after initiating treatment.