Brimonidine tartrate: Phase III data

A pair of identical, double-blind, U.S. and Canadian Phase III trials in patients with moderate to severe erythema associated with rosacea showed that once-daily 0.5% topical brimonidine tartrate gel for 4 weeks met the primary endpoint in both trials of a greater composite success rate, defined as a 2-grade improvement on both CEA and PSA scores over 12 hours, on day 29 vs. vehicle gel controls (p<0.001 for all). In study A in 260 patients, brimonidine led to success rates of 31.5% at 3 hours, 30.7% at 6 hours, 26% at 9 hours and 22.8% at 12 hours on day 29 vs. 10.9%, 9.4%, 10.2% and 8.6%, respectively, for vehicle. Additionally, a significantly greater proportion of patients receiving brimonidine achieved a 1-grade improvement on both CEA and PSA scores at 30 minutes after application on day 1, a secondary endpoint, vs. vehicle (27.9% vs. 6.9%, p<0.001).

In study B in 293 patients, brimonidine led to success rates of 25.4% at 3 hours, 25.4% at 6 hours, 17.6% at 9 hours and 21.1% at 12 hours on day 29 vs. 9.2%, 9.2%, 10.6% and 9.9%, respectively, for vehicle. Additionally, a significantly greater proportion of patients receiving brimonidine achieved a 1-grade improvement on both CEA and PSA scores at 30 minutes after application on day 1, a secondary endpoint, vs. vehicle (28.4% vs. 4.8%, p<0.001). No tachyphylaxis, rebound or aggravation of other disease signs were observed in either trial. Both trials consisted of a 4-week treatment phase and a 4-week follow-up period. Data were published in the Journal of Drugs in Dermatology. ...