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news.Connetics Corporation, a dermatology focused pharmaceutical developer, is to resume development of Extina, an investigative new drug formulation of 2% ketoconazole for the treatment of seborrheic dermatitis, after concluding additional discussions with the FDA about required further testing.
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The company’s original application for Extina was turned down in the form of a non-approvable letter received in November 2004 due to insufficient clinical data. As a result of meetings between Connetics and FDA officials regarding requirements for the Extina application, Connetics will recommence development by initiating a final phase III trial intended to demonstrate that Extina is superior to placebo foam.
The phase III trial is expected to commence in the third quarter of 2005 which should position Connetics to resubmit its appliction for Extina to the FDA by the end of 2006, with an anticipated review time of up to six months. The company believes this timetable would mean delivery onto the market some time in 2007.
“Over the past several months we have worked with the FDA to get clarity on the requirements for FDA approval of Extina,” said Thomas Wiggans, CEO of Connetics. “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.”