FDA Approves New Option for Facial Erythema Associated with Rosacea
The FDA has approved Rhofade (oxymetazoline hydrochloride) cream, 1%, for the topical treatment of persistent facial erythema associated with rosacea.
Rhofade is the first alpha1A adrenoceptor agonist approved for the treatment of rosacea in adults.
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The approval was based upon the results of 2 randomized, double-blind, parallel-group, vehicle-controlled clinical trials involving 885 participants. In both trials, the primary efficacy endopoint, defined as the proportion of patients with at least a 2-grade reduction in erythema from baseline, 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.”
The most common adverse reactions included application site dermatitis, worsening inflammatory lesions, application site pruritus, application site erythema, and application site pain.
—Michael Potts
Reference:
Allergan. Allergan announces FDA approval of Rhofade™ (oxymetazoline hydrochloride) cream, 1% for the topical treatment of persistent facial erythema associated with rosacea in adults [press release]. January 19, 2017. http://www.prnewswire.com/news-releases/allergan-announces-fda-approval-of-rhofade-oxymetazoline-hydrochloride-cream-1-for-the-topical-treatment-of-persistent-facial-erythema-associated-with-rosacea-in-adults-300393385.html.