CONNETICS REPORTS POSITIVE RESULTS FROM SECOND EXTINA TRIAL

Connetics has announced positive results of a Phase III clinical trial of Extina (ketoconazole) Foam 2 percent, formulated in VersaFoam-HF, for the treatment of seborrheic dermatitis.

The study was a four-week, double-blinded, active- and placebo-controlled trial that included 1,162 patients at 24 centers in the United States. The trial was designed to demonstrate that Extina is superior to placebo foam. The results showed a 56 percent response for Extina and a 42 percent response for placebo foam, a statistically significant difference. The trial also demonstrated non-inferiority compared with standard ketoconazole cream. There was a 56 percent response for Extina and a 56 percent response for the reference ketoconazole product.

The company submitted a new drug application to the FDA in July 2003. In November 2004, Connetics received a not approvable letter for based primarily on the FDA's conclusion that clinical trials did not demonstrate statistically significant superiority of Extina to placebo foam. As a result of meetings with the FDA, the company announced that it would recommence development by conducting another Phase III trial

Ketoconazole is used to treat a variety of fungal infections, including seborrheic dermatitis.