You are here

FDA Accepts Sebazole NDA

PRINCETON, NJ--(MARKET WIRE)--Dec 9, 2005 -- Barrier Therapeutics, Inc. (NasdaqNM:BTRX - News), 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 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.

About Seborrheic Dermatitis
Seborrheic dermatitis is a skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The condition often recurs, thereby requiring re-treatment over time. Seborrheic dermatitis affects approximately 3% to 5% of the U.S. population. Barrier Therapeutics estimates that approximately 8.5 to 14.3 million people in the U.S. are affected. Current prescription therapies consist primarily of topical ketoconazole creams and topical steroids. These treatments typically require multiple applications per day over periods of up to four weeks to be effective.

Source: Barrier Therapeutics, Inc.

Recent Headlines

FDA Removes Boxed Warning With Drug’s Fifth Approval
Overeager Use of Recommendations Creates Problems
Averts Disease Worsening, Reduces Potential for Blindness
Risk May Remain for 6 Months After Treatment
Artificial Intelligence Enables Platform to Detect Amyloid PET Status
Kadcyla Cut Risk of Recurring Disease by Half Compared to Herceptin
May Lead to Personalized Treatment for Schizophrenia, Other Illnesses
First Medicines for Adults With Wild-type or Hereditary ATTR-CM