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Extina To Resume Development With New Phase 3 Trial
The Phase III trial is expected to commence in the third quarter of 2005 which should position Connetics to resubmit the NDA for Extina to the FDA by the end of 2006 with an anticipated review time of up to six months. Incremental development expenses associated with Extina for the second half of 2005 are estimated to be approximately $1.0 million.
"Over the past several months we have worked with the FDA to get clarity on the requirements for FDA approval of Extina," said Thomas G. Wiggans, chief executive officer of Connetics. "Returning Extina to our pipeline is an important decision that leverages our formulation and development achievements with the drug candidate and positions Connetics to potentially launch the product in 2007. We believe that the design of the proposed study will provide the data necessary to address the FDA's desire to see statistical superiority to placebo foam. We continue to view Extina as an important product that addresses a significant need within the topical anti-fungal market."
Acting on the Company's original NDA submission in November 2004, and consistent with prior disclosure by the Company, the FDA concluded that Extina did not show superiority to placebo foam. Previously announced results from Connetics' Phase III clinical trial with Extina demonstrated non-inferiority to Nizoral(R) (ketoconazole) 2% Cream as measured by the endpoint of the Investigator's Static Global Assessment.
Source: Connetics Corporation