Custom Search

News

Friday 09 December 2005

FDA Accepts Sebazole NDA

By: Market Wire

Barrier Therapeutics, Inc., a pharmaceutical company developing and commercializing products in the field of dermatology, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for Sebazole(TM) (ketoconazole USP 2%) topical gel for the treatment of seborrheic dermatitis.

Sebazole is a topical formulation consisting of 2.0% 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.

"Sebazole is our second product candidate currently under active FDA review, following Vusion(TM), which is a significant milestone for Barrier," stated Geert Cauwenbergh, Ph.D., Chairman and CEO of Barrier Therapeutics, Inc. "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."

The NDA submission for Sebazole was based on the results of a pivotal confirmatory Phase 3 clinical trial in addition to the results from two prior supportive Phase 3 trials. In the confirmatory two arm Phase 3 pivotal study, which enrolled 459 subjects at 24 centers across the United States, Sebazole achieved statistical significance at the primary endpoint as compared to the vehicle treated patients (p=0.001). The study was a double blind, vehicle-controlled study of once-a-day Sebazole treatment compared to the vehicle (the waterless gel formulation alone). 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 (U.S. study: p < 0.001 and European study: p=0.021). The earlier two Phase 3 studies had four treatment arms (Sebazole, the vehicle alone, the vehicle containing a topical steroid known as desonide, and the combination of desonide with Sebazole). The primary efficacy endpoint for all three Phase 3 studies was the proportion of subjects who were effectively treated at day 28, which is 14 days following the end of a two-week treatment period.

The filing of an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted.

Read Original Text

Use of this site is subject to the following terms of use