dm+d

29129004

New Medicines

RhofadeRosacea-associated persistent facial erythema (redness) in adults

Information

Rhofade
New formulation
EPI Healthcare
EPI Healthcare

Development and Regulatory status

None
None
Launched

Oct 19: Aclaris and EPI Health have entered into a purchase agreement whereby Aclaris sold the worldwide rights to Rhofade® [6].


Nov 18: On November 30, 2018, Allergan divested Rhofade® to Aclaris Therapeutics, Inc [5].


May 17: Launched in the US [4].


Jan 17: Allergan plans to launch Rhofade in the US in May 17 [2].


Jan 17: Approved in the US for topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29 [2].

Category

Alpha-adrenergic receptor agonist, topical cream formulation.
Prevalence of rosacea is highest among Indo-Eurasians. In Europe, there is an increasing prevalence from South to North: in Germany prevalence is 2.2%, in Sweden 10% and in Estonia 22%. Rosacea is primarily a condition of the white population, is three times more common in women than in men and has a peak age of onset between 30 and 60 years [1].
Rosacea-associated persistent facial erythema (redness) in adults
Topical

Trial or other data

Jan 17: PIII trials are NCT01735201 and NCT02131636 [3].


Jan 17: 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 [2].