llergan Announces FDA Approval Of RHOFADE™ (Oxymetazoline Hydrochloride) Cream, 1% For The Topical Treatment Of Persistent Facial Erythema Associated With Rosacea In Adults
"The FDA approval of RHOFADE™ exemplifies Allergan's commitment to continuing to address unmet patient needs through innovation in medical dermatology," said David Nicholson, Chief R&D Officer of Allergan plc. "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."
The National Rosacea Society (NRS) estimates that approximately 16 million Americans are affected by rosacea.2 Persistent facial redness is cited as the most common sign of rosacea, and may resemble a flushing or sunburn that does not go away.3 Typical triggers include sun exposure, stress, weather, food, exercise and/or products.4 In an NRS survey, 65% of rosacea patients surveyed said their symptoms first appeared between 30-60 years of age.5
"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," said Dr. Robert Weiss, Clinical Trial Investigator and Director of Maryland Laser, Skin & Vein Institute. "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."
In two clinical trials, a once-daily application of RHOFADE™ 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 (improvement) from baseline (pre-dose 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 versus vehicle. CEA and SSA also measured at Days 1 and 15 at hours 3, 6, 9, and 12.1
The clinical trials were identical, multicentered, randomized, double-blind, parallel-group, and vehicle-controlled in moderate or severe patients, N=885, 18 years or older.
In both pivotal trials, the primary efficacy endpoint 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.1
RHOFADE™ will be available for commercial supply starting May 2017 in the United States.
RHOFADETM (oxymetazoline hydrochloride) cream, 1% Indication and ISI
Indication
RHOFADETM (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS"
Potential Impacts on Cardiovascular Disease
Alpha-adrenergic agonists may impact blood pressure. RHOFADETM should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.
Potentiation of Vascular Insufficiency
RHOFADETM should be used with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.
Risk of Angle Closure Glaucoma
RHOFADETM may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.
ADVERSE REACTIONS
The most commn adverse reactions for RHOFADETM were: application site dermatitis 2 %, worsening inflammatory lesions of rosacea 1%, application site pruritus 1%, application site erythema 1%, and application site pain 1%
