Desilux, a low-potency topical steroid, is the first drug formulated in the company’s patented “emollient (soothing) foam delivery vehicle”. The company says that the foam does not feel greasy like an ointment or a cream.
The phase III trial included 581 patients from age three months to 17 years and was designed to demonstrate superiority of Desilux over placebo foam. In the study, subjects received either Desilux or placebo foam twice-daily for four weeks, followed by three weeks of follow up. The data from the trial demonstrate a consistently robust and highly statistically significant treatment effect for Desilux compared to placebo.
The proportion of patients achieving treatment success on the primary endpoint was 39% for Desilux and 9% for placebo foam. The data from the trial also demonstrated that Desilux was safe and well tolerated, with the most frequently observed side effects mild in nature and largely limited to application site reactions.
“We are enthusiastic about the strength of the Desilux pivotal data, and look forward to the prospect of bringing to market our first drug candidate in Connetics’ patented emollient foam delivery vehicle,” said Dr Lincoln Krochmal, executive vice president of Research and Product Development for Connetics.