FDA Approves Rhofade Rosacea Treatment

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"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."   

Allergan Announces FDA Approval Of RHOFADE™ (Oxymetazoline Hydrochloride) Cream, 1% For The Topical Treatment Of Persistent Facial Erythema Associated With Rosacea In Adults, Allegan

Prescribing Information

"Rhofade will be available commercially from May 2017 in the U.S. Allergan claims that Rhofade is the first and only alpha1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults.,,The approval was based on two clinical studies both of which met the primary efficacy endpoint. The clinical trials, which enrolled a total of 885 patients, were identical, multi-centered, randomized, double-blinded, parallel-group and vehicle-controlled in moderate or severe patients aged 18 years or older. Both the studies demonstrated that Rhofade was more effective than vehicle in reducing persistent facial erythema associated with rosacea in adults."

Allergan (AGN) Rhofade Cream for Rosacea Approved in U.S., Zacks Equity Research, Yahoo Finance

Rhofade, also known as oxymetazoline hydrochloride cream (1 percent strength), is a topical cream made to treat persistent facial erythema (redness), as opposed to the other symptoms of rosacea, like easy flushing, red bumps and pus pimples, skin burning, and sensitivity, explains Joshua Zeichner, a New York City dermatologist.  

FDA Approves Rhofade Rosacea Treatment, by Sarah Kinonenat, Allure

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.

FDA OKs New Cream for Facial Erythema in Rosacea in Adults, Megan Brooks Medscape

Rhofade, also known as oxymetazoline hydrochloride cream (1 percent strength), is a topical cream made to treat persistent facial erythema (redness), as opposed to the other symptoms of rosacea, like easy flushing, red bumps and pus pimples, skin burning, and sensitivity, explains Joshua Zeichner, a New York City dermatologist.

How does Rhofade work? Rosacea sufferers experience an overactivity of blood vessels in the face, which is why those with rosacea flush easier than others. Over time, the persistent flushing can lead to what Zeichner likens to fixed background redness. "Rhofade directly addresses this redness by constricting the blood vessels," he explains. teenvogue

David Pascoe has an excellent article on Who Should NOT Use Rhofade. In another article, David reports, "Going on the published clinical data, basically one in 6 or 7 users of RHOFADE will have a 2-grade improvement in their facial redness, typically for 12 hours, and continuing for 29 once-daily uses."

"Apparently, the entry of the RHOFADE, which will be commercially available from May 2017, may just be timely. For a while now physicians have not been able to efficiently address the facial erythema for lack of treatment options. The best they have been doing is helping their patients manage the triggers. That means the availability of RHOFADE is a plus to the delivery of their goals."

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