Rhofade cream (oxymetazoline HCI cream 1.0%) approved by FDA for persistent facial erythema associated with rosacea- Allergan

Allergan announced the approval of Rhofade cream (oxymetazoline HCI cream 1.0%) by the U.S. FDA for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29. In two clinical trials, a once-daily application of Rhofade was proven to reduce persistent facial erythema associated with rosacea through 12 hours. The primary efficacy endpoint was at day 29 and defined as the proportion of patients with at least a 2-grade reduction in erythema (improvement) from baseline (pre-dose on day 1) on both the clinician erythema assessment (CEA) and subject self-assessment (SSA) (composite success) measured at hours 3, 6, 9 and 12 versus vehicle. CEA and SSA also measured at Days 1 and 15 at hours 3, 6, 9, and 12.1.

The clinical trials were identical, multicentered, randomized, double-blind, parallel-group, and vehicle-controlled in moderate or severe patients, N=885, 18 years or older. In both pivotal trials, the primary efficacy endpoint was met. The proportion of patients achieving composite success were as follows: at hours 3, 6, 9 and 12 results in study 1 were Rhofade (N=222) 12%, 16%, 18%, 15% versus Vehicle (N=218) 6%, 8%, 6%, 6% and in study 2 were Rhofade (N=224) 14%, 13%, 16% and 12% versus Vehicle (N=221) 7%, 5%, 9% and 6%. Rhofade was proven more effective than vehicle in reducing persistent facial erythema associated with rosacea in adults.