Allergan has received U.S. Food and Drug Administration (FDA) approval of RHOFADE (oxymetazoline hydrochloride) cream 1% for the topical treatment of persistent facial erythema associated with rosacea in adults.
Approval was based on two identical multicenter, randomized, double-blind, parallel-group, vehicle-controlled clinical studies in which a once-daily application of RHOFADE (N = 885) 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 from baseline (pre-dose on day 1). Improvement was measured at hours 3, 6, 9 and 12 using both clinician erythema assessment (CEA) and subject self-assessment (SSA).. In the first study, the proportion of RHOFADE patients (N = 222) achieving composite success at hours 3, 6, 9 and 12 was 12%, 16%, 18% and 15% versus vehicle (N = 218) 6%, 6%, 8% and 6%. In the second study, the proportion of patients (N = 224) achieving composite success was 14%, 13%, 16% and 12% versus vehicle (N = 221) 7%, 5%, 9% and 6%.
“We know persistent facial erythema associated with rosacea is a challenge for patients and physicians and having options can help in treating the disease. RHOFADE is the first and only alpha1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults. The FDA approval of RHOFADE represents a new prescription treatment that can effectively help physicians and their patients manage this condition,” said David Nicholson, chief R&D officer of Allergan.
RHOFADE will be available for commercial supply starting May 2017 in the U.S. For more information, visit www.rhofade.com.