Drugs Xagena
Rhofade ( Oxymetazoline hydrochloride ) cream has been approved by the U.S. Food and Drug Administration ( FDA ) for the topical treatment of persistent facial erythema associated with rosacea in adults.
Approval was based on two clinical studies.
Rhofade is the first and only alpha1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults.
The National Rosacea Society ( NRS ) estimates that approximately 16 million Americans are affected by rosacea. Persistent facial redness is cited as the most common sign of rosacea, and 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 surveyed said their symptoms first appeared between 30-60 years of age.
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.
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. ( Xagena )
Source: Allergan, 2017
XagenaMedicine_2017
