You are here

Non-Approvable Letter Issued for Extina, Treatment of Seborrheic Dermatitis

PALO ALTO, Calif.--(BUSINESS WIRE)--Nov. 23, 2004--Connetics Corporation (Nasdaq:CNCT - News), a specialty pharmaceutical company focused on dermatology, today announced that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter (dated November 23, 2004) for Extina®, an investigational new drug formulation of 2% ketoconazole for the treatment of seborrheic dermatitis. The FDA concluded that Extina was not effective for the treatment of seborrheic dermatitis because it was not superior to placebo foam.

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

Recent Headlines

Patients Had Improved Lung Function, Fewer Exacerbations
Particularly Serious: Antidepressants, Drugs for Parkinson’s and Epilepsy
Drug “Remarkably Effective” at Killing Range of Gram-Positive Bacteria
Up to 70% Greater Risk of Bacterial Infection, 48% Risk for Fungal Infection
Most Women Undergoing Surgery for Suspected Cancer Do Not Have It
Specific Monoclonal Antibodies Ensure Extreme Sensitivity, Accuracy
Record-High Number of Cases in France, Italy, Greece, Other Locations
Will Have a Longer Shelf Life Than Current, Expired Stockpile