Topical Treatment for Facial Redness Receives FDA Approval

The FDA has approved Allergan’s newest topical treatment for persistent facial erythema. Rhofade (oxymetazoline hydrochloride) cream, 1%, is indicated to improve symptoms of redness associated with rosacea in adults through 12 hours.

The once-daily treatment’s approval is based on 2 clinical studies that tested the primary efficacy endpoint, and was proven to reduce persistent facial erythema. The clinical trials were identical, randomized, double-blind, parallel-group, and vehicle-controlled in moderate or severe patients aged 18 years or older. Rhofade met its primary efficacy endpoint in both trials.

Approximately 16 million Americans are affected by rosacea, the National Rosacea Society estimates, and persistent facial redness is a common symptom that may resemble a flushing or sunburn. Sun exposure, stress, weather, food, exercise and/or products are typical triggers.

Rhofade will be commercially available starting May 2017 in the US market.

Reference

Allergan Announces FDA Approval Of RHOFADE (Oxymetazoline Hydrochloride) Cream, 1% For The Topical Treatment Of Persistent Facial Erythema Associated With Rosacea In Adults [news release]. Dublin. Allergan website. http://www.allergan.com/NEWS/News/Thomson-Reuters/Allergan-Announces-FDA-Approval-Of-RHOFADE-Oxymet. Accessed Jan. 19, 2017.