FDA OKs New Cream for Facial Erythema in Rosacea in Adults

Megan Brooks

Disclosures

January 19, 2017

The US Food and Drug Administration (FDA) has approved oxymetazoline hydrochloride 1% cream (Rhofade, Allergan) for the topical treatment of persistent facial erythema associated with rosacea in adults.

Persistent facial erythema associated with rosacea is "a challenge for patients and physicians, and having options can help in treating the disease," David Nicholson, Allergan's head of research and development, said in a news release announcing approval.

"Rhofade is the first and only alpha1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults. The approval of Rhofade represents a new prescription treatment that can effectively help physicians and their patients manage this condition," Nicholson noted.

The approval was based on two identical, multicenter, randomized, double-blind, parallel-group, vehicle-controlled studies involving 885 adults aged 18 years and older with moderate or severe rosacea.

In both trials, Rhofade applied once daily reduced persistent facial erythema associated with rosacea through 12 hours, the company said.

Both trials met the primary efficacy endpoint, defined as the proportion of patients at day 29 with at least a 2-grade improvement in erythema from baseline (predose on day 1) on both the clinician erythema assessment and subject self-assessment (composite success) measured at hours 3, 6, 9, and 12 hours vs vehicle.

The proportion of patients taking Rhofade who achieved composite success at 3, 6, 9, and 12 hours in study 1 were 12%, 16%, 18%, and 15%, respectively, vs 6%, 8%, 6%, and 6% in patients using vehicle. The corresponding percentages in study 2 were 14%, 13%, 16%, and 12% with Rhofade, vs 7%, 5%, 9%, and 6% for vehicle control.

Rhofade proved more effective than vehicle in reducing persistent facial erythema associated with rosacea in adults, the company said.

The most common adverse reactions with Rhofade were application site dermatitis (2%) and worsening inflammatory lesions of rosacea, application site pruritus, application site erythema, and application site pain (1% each).

The National Rosacea Society estimates that roughly 16 million Americans have rosacea.

"Historically, there haven't been many options available to help physicians address persistent facial erythema, and often we ended up just helping our patients identify and manage triggers, which can lead to frustration for both the doctor and patient," Robert Weiss, MD, clinical trial investigator and director of Maryland Dermatology Laser, Skin and Vein Institute in Hunt Valley, Maryland, said in the release. "With the approval of Rhofade, doctors will now be able to provide their patients with an effective once-daily treatment option to help manage this condition."

The company notes that alpha-adrenergic agonists may affect blood pressure and says Rhofade should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension. Rhofade should also be used with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome. Rhofade may increase the risk for angle closure glaucoma in patients with narrow-angle glaucoma.

Allergan says Rhofade will be available in May 2017.

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