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news.The FDA has accepted Barrier Therapeutics' new drug application for Sebazole, a topical gel for the treatment of seborrheic dermatitis, a disease which causes flaking of the skin.
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“If approved by the FDA, we believe Sebazole will provide significant patient benefits in the non-steroidal management of seborrheic dermatitis, with less risk for irritation and a more convenient treatment regimen as compared to currently available ketoconazole cream products,” stated Dr Geert Cauwenbergh, Chairman and CEO of Barrier Therapeutics.
Sebazole is a topical formulation consisting of 2% ketoconazole, an antifungal agent, formulated in a waterless gel for once-daily application. The NDA for Sebazole topical gel was submitted to the FDA in September 2005.
The NDA submission for Sebazole was based on the results of a pivotal confirmatory phase III clinical trial in addition to the results from two prior supportive phase III trials.
In the confirmatory two arm phase III pivotal study, which enrolled 459 subjects at 24 centers across the US, Sebazole achieved statistical significance at the primary endpoint as compared to the vehicle treated patients.
Sebazole also achieved statistical significance for the same primary efficacy endpoint in both of the prior Phase 3 clinical trials, which enrolled a combined total of 474 patients in the Sebazole and vehicle arms at 47 centers in the United States and Europe.