You are here
Non-Approvable Letter Issued for Extina, Treatment of Seborrheic Dermatitis
Connetics announced in April 2003 that results from its Phase III clinical trial with Extina demonstrated non-inferiority to Nizoral® (ketoconazole) 2% Cream as measured by the endpoint of the Investigator's Static Global Assessment. Connetics also announced the results did not achieve statistical superiority versus placebo foam.
"The FDA's decision is disappointing and surprising. Based on discussions with the FDA regarding the requirements for the Phase III trial, we believe Extina met the study endpoints and that the NDA was approvable," said Thomas G. Wiggans, Connetics' Chief Executive Officer. "We believe that Extina demonstrated efficacy and warranted approval. However, under the circumstances, we will evaluate all options for Extina."
Commenting on the company's near-term commercial prospects, Mr. Wiggans added, "With our recently expanded and highly experienced sales force, we project continued growth from our core brands in 2005, and we are prepared for the commercial launch of Evoclin(TM), our new acne foam product, early next month. In addition, we have submitted an NDA for Velac® and have a robust pipeline of clinical and formulation-stage product candidates. We believe that any potential lost revenue for Extina in 2005 will be offset by expense savings as we will not be incurring the planned commercialization costs for Extina."
Source: Connetics Corporation