The U.S. FDA has approved roflumilast 0.3% cream for the topical treatment of plaque psoriasis in patients aged 12 years and above. Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4). Arcutis Biotherapeutics announced the approval on July 29. Oral roflumilast was approved in 2011 for treating chronic obstructive pulmonary disease (COPD). In both short- and long-term trials, Dr. Mark Lebwohl, MD, Dean of Clinical Therapeutics and Professor of Dermatology at the Icahn School of Medicine at Mount Sinai, stated that the treatment with topical roflumilast significantly reduced psoriasis symptoms in both short- and long-term trials.

He added that the roflumilast is not a steroid, hence it does not have the risk of topical steroid-related side effects associated with chronic use, and in a clinical trial, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts. FDA approval was based on data from two phases of three randomized, double-blind, vehicle-controlled trials. In the trial, 42.4% and 37.5% of the patients treated with topical roflumilast showed a decline in their symptoms in comparison to 6.1% and 6.9% in the control group, respectively.

At 8 weeks, 72% and 68% of patients treated with roflumilast met the intertriginous endpoint, respectively. In general, the cream was well tolerated, but there were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%). However, Dr. Lebwohl noted that these events were observed in the control group. 

(Source: https://www.medscape.com/viewarticle/978324?src= )