FDA Approves Rhofade Cream for Facial Erythema Associated With Rosacea in Adults

Erythema is reduced in two pivotal trials

The FDA has approved oxymetazoline hydrochloride cream 1% (Rhofade, Allergan) for the topical treatment of persistent facial erythema associated with rosacea in adults. The product will be commercially available in the United States starting in May 2017.

The FDA’s approval was based on data from two clinical studies of once-daily oxymetazoline cream. The two identical multicenter, randomized, double-blind, parallel-group, vehicle-controlled studies involved a total of 885 adults (18 years of age and older) with moderate or severe disease. The primary efficacy endpoint was the proportion of patients with at least a two-grade reduction in erythema (improvement) from baseline (predose 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 compared with vehicle on day 29. CEA and SSA were also measured on days 1 and 15 at hours 3, 6, 9, and 12.

The primary efficacy endpoint was met in both studies. In study 1, the proportions of patients achieving composite success at hours 3, 6, 9, and 12 were 12%, 16%, 18%, and 15%, respectively, for oxymetazoline cream (n = 222) compared with 6%, 8%, 6%, and 6% for vehicle (n = 218). In study 2, the corresponding values were 14%, 13%, 16%, and 12% for oxymetazoline cream (n = 224) compared with 7%, 5%, 9%, and 6% for vehicle (n = 221).

The National Rosacea Society (NRS) estimates that approximately 16 million Americans have the disease. Persistent facial erythema is cited as the most common sign of rosacea. The redness may resemble a flushing or sunburn that does not go away. Typical triggers include sun exposure, stress, weather, food, exercise, and/or products. In an NRS survey, 65% of rosacea patients said their symptoms first appeared between 30 to 60 years of age.

Oxymetazoline is an alpha-adrenergic agonist and should be used with caution in patients with severe or unstable/uncontrolled cardiovascular disease, orthostatic hypotension, uncontrolled hypertension/hypotension, cerebral or coronary insufficiency, Raynaud’s phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome.

In clinical studies, the most common adverse effects of oxymetazoline cream included application-site dermatitis (2%), pruritus (1%), erythema (1%), pain (1%), and worsening inflammatory lesions of rosacea (1%).

Source: Allergan; January 19, 2017.